Indications, safety, and warnings for Spinal Cord Stimulator Systems

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems N/A

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Patients The Boston Scientific Spinal Cord Stimulator (SCS) Systems* are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following:

• Failed back surgery syndrome,
• Complex Regional Pain Syndrome (CRPS) Types I and II,
• Intractable low back pain and leg pain,
• Diabetic Peripheral Neuropathy of the lower extremities,
• Radicular pain syndrome,
• Radiculopathies resulting in pain secondary to failed back syndrome or herniated disc,
• Epidural fibrosis,
• Degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions),
• Arachnoiditis,
• Multiple back surgeries.

The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.
*The Boston Scientific Spinal Cord Stimulator (SCS) Systems include the following:

• Precision™ System
• Precision Spectra™ System
• Precision Novi™ System
• Precision Montage™ MRI System
• Spectra WaveWriter™ System
• WaveWriter Alpha™ System
• WaveWriter Alpha™ Prime System

Note: CRPS I was previously referred to as Reflex Sympathetic Dystrophy (RSD) and CRPS II was previously referred to as causalgia.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Implantable Pulse Generators N/A
Boston Scientific Spinal Cord Stimulator Systems N/A
Bionic Navigator™ 3D System N/A
Bionic Navigator™ 3D 4.0 System N/A
Bionic Navigator™ 1.2 Software N/A
Charger 2.0 N/A
Freelink™ Remote Control N/A
Surgical Leads N/A
Avista™ MRI xx cm 8 Contact Lead Kit N/A

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord This manual is intended for use by physicians and other healthcare professionals (HCPs) involved in managing patients with a WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with ImageReady™ MRI Technology, as well as radiologists and other HCPs involved in performing magnetic resonance imaging (MRI) scans on such patients.

References to the Boston Scientific Spinal Cord Stimulator (SCS) System include the following implantable pulse generators (IPG):

• WaveWriter Alpha IPG
• WaveWriter Alpha 16 IPG
• WaveWriter Alpha Prime IPG
• WaveWriter Alpha Prime 16 IPG

WaveWriter Alpha and WaveWriter Alpha 16 are rechargeable IPGs. References to the Charging System or charging process are applicable only when using a rechargeable SCS Stimulator.
WaveWriter Alpha Prime and WaveWriter Alpha Prime 16 are a non-rechargeable IPGs.
The Boston Scientific SCS System with ImageReady MRI Technology is “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in this manual.
Note: The term “Stimulator” in this manual references the Implantable Pulse Generator (IPG), unless specifically

mySCS™ GOTherapy Controller App
The Therapy Controller App is intended to communicate with and control the compatible Boston Scientific Stimulator.

Precision™ Adapter S8
The Precision™ Adapter S8 is a 1 x 8 in-line connector that is designed to connect specific St. Jude (Abbott) Leads to the Boston Scientific SCS implantable pulse generators, OR Cables, and Lead Extensions, as part of a spinal cord stimulation procedure.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters N/A

Precision™ Adapter M8
The Precision™ Adapter M8 is a 1 x 8 in-line connector that is designed to connect specific Medtronic Leads to the Boston Scientific SCS Implantable Pulse Generators, OR Cables, Leads, and Lead Extensions, as part of a spinal cord stimulation procedure.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems
Patients contraindicated for permanent Spinal Cord Stimulation (SCS) therapy are those who:

• are unable to operate the System
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical candidates
• are pregnant

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Implantable Pulse Generators N/A
Boston Scientific Spinal Cord Stimulator Systems N/A
Bionic Navigator™ 3D System N/A
Bionic Navigator™ 3D 4.0 System N/A
Bionic Navigator™ 1.2 N/A
Charger 2.0 N/A
Freelink™ Remote Control N/A
Surgical Leads N/A
Percutaneous Leads N/A
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems N/A
Avista™ MRI xx cm 8 Contact Lead Kit N/A
mySCS™ GOTherapy Controller App N/A
Precision™ Adapter M8 N/A
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters N/A
Precision™ Adapter M8 N/A

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems
Unauthorized modification to the medical devices is prohibited. System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification.
Heat Due to Charging (for rechargeable IPGs). Patients should not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt or an adhesive patch, may result in a burn. If patients experience pain or discomfort, they should cease charging and contact Boston Scientific.
Magnetic Resonance Imaging (MRI).

• The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems are “MR Conditional”. An MRI examination can be conducted safely only when using a 1.5 Tesla horizontal closed-bore whole-body MRI system for the MRI scan and following all instructions in the supplemental manual “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems”. The 1.5T MRI system can be configured to use the Full Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of any type. It is important to read the information in the supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a WaveWriter Alpha or WaveWriter Alpha Prime SCS System. The “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems” manual appears on the Boston Scientific websites (www.bostonscientific.com/ImageReady and www.bostonscientific-elabeling.com). MRI examinations performed on patients with the WaveWriter Alpha or WaveWriter Alpha Prime SCS System using open sided MRI systems, or other types of MRI systems operating at other static magnetic field strengths (higher or lower), have not been assessed and, as such, should not be performed.
• External Devices: External components (for example, the ETS, Remote Control, and Battery Charger) are MR Unsafe. They must not be taken into any MR environment such as the MRI scanner room.

Pediatric Use. The safety and effectiveness of stimulation has not been established for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on SCS patients with a stimulator. The energy generated by diathermy can be transferred through the Stimulator system, causing tissue damage at the lead site and resulting in severe injury or death. The IPG, whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Do not implant the device if the case is damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Patients should be advised to turn down the amplitude or turn off the IPG before making posture changes. If using therapy that does not produce a sensation (subperception), postural changes are less likely to affect the patient.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with Remote Control communication. If an electromagnetic field is strong enough to turn stimulation off, this will be temporary and stimulation will automatically return or stimulation can be turned on using the remote control once the electromagnetic f ield is removed. Patients should be advised to avoid or exercise care around the following:

• Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments: Patients should proceed with caution, ensuring that they move through the center of the detector as quickly as possible. Interference from these devices should not cause permanent damage to the implanted device.
• Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand-held scanners: Patients should request assistance to bypass the security screener and advise the security staff that they have an implanted medical device. If patients must pass through the security screener, they should move through the security screener quickly and stay as far as allowed from the screener.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can broadcast a radio frequency (RF) signal. The high energy fields produced by these systems may interfere with the operation of the Remote Control and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as Wi-Fi routers, Cordless Phones, Bluetooth® Wireless streaming devices, Baby Monitors, Microwave Ovens.

Note: When in close proximity, equipment that generate strong electromagnetic f ields might cause unintended stimulation or interfere with wireless communication even if they comply with CISPR requirements.
Charging a Mobile Device with Therapy Controller App. Do not use the Therapy Controller App while the mobile device is charging. The effect of using the Therapy Controller App while charging the mobile device has not been evaluated.
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
Instructions for the Physician
Use in diabetic patients - Surgical complications and adverse events may be more frequent and severe in diabetic patients. The following additional considerations should be made for diabetic patients including:

• A preoperative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) ≥ 8% (64 mmol/mol).
• Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to continue to monitor levels as they may fluctuate as a response to surgery or to complications. Implanting physicians and/or anesthesiologists should consult practice guidelines for the intraoperative management of diabetic patients.
• Closely monitor patient for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in diabetic patients.

Stimulation modes. Only paresthesia-based stimulation mode has been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Patients
Unauthorized Modification: Do not make unauthorized changes to the medical devices. The quality of the devices could be compromised and you may be harmed or injured, if unauthorized changes are made.
Heat Due to Charging (for rechargeable Stimulators). Do not charge while sleeping. This may result in a burn. Failure to use the Charger Belt or an adhesive patch, as shown in your Charger Handbook, may result in a burn. If you experience pain or discomfort, cease charging and contact your healthcare provider.
Magnetic Resonance Imaging (MRI). You may be able to have an MRI examination when specific conditions are met. These conditions are defined in the supplemental manual ImageReady™ MRI Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.
For WaveWriter Alpha System implants using Precision™ Adapters M8 & Precision™ Adapters S8, refer to ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters.
Your healthcare provider should read this information in its entirety. Your healthcare provider should ensure all conditions are met before conducting and recommending an MRI exam.
The ImageReady™ Guidelines appear on the Boston Scientific website (www.bostonscientific-elabeling.com and www.bostonscientific.com/ImageReady).
External Devices. The SCS System devices that are outside of your body are MR Unsafe. Do not take them into any MRI environment. Examples of devices that are outside of the body are:

• Charging System
• Remote Control
• Mobile device with mySCS™ Go Therapy Controller App (Therapy Controller)
• Trial Stimulator
• OR Cable
• Accessories

Pediatric Use. The safety and effectiveness of stimulation has not been established for pediatric use.
Diathermy. You should not have any form of diathermy either as treatment for a medical condition or as part of a surgical procedure. The energy generated by diathermy can be sent through your Stimulator System. This can cause tissue damage, severe injury, or death. The Stimulator may be damaged.
Cardiac Pacemakers. Stimulators may interfere with use of other active implantable devices. Some examples of active implantable devices are pacemakers and implantable cardiac defibrillators (ICDs). Tell your healthcare provider of your Stimulator before adding other implantable device therapies. Your healthcare provider should know, so that safety measures are taken.
Implant Damage. Burns may result if the pulse generator case is damaged and patient tissue is exposed to battery chemicals.
Posture. Changes in posture or sudden movements may cause decreases or increases in the perceived stimulation level.

• Keep the Remote Control or Therapy Controller with you at all times.
• Turn stimulation down or off before making posture changes.
• Turn off stimulation immediately, if unpleasant sensations occur.

Postural changes are less likely to affect you when using therapy that does not produce a sensation.
Electromagnetic Interference. Strong electromagnetic fields can potentially:

• Turn stimulation off.
• Cause temporary unpredictable changes in stimulation.
• Interfere with system communication.

Strong electromagnetic fields may turn stimulation off for a short period of time. Once the electromagnetic field is removed, stimulation may return on its own. Stimulation may also be turned on using the Remote Control or Therapy Controller.

You should avoid or exercise care around the following:

• Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments.
  • If you must proceed through the detector, proceed with caution, ensuring that you move through the center of the detector as quickly as possible. Interference from these devices should not cause permanent damage to the implanted device.
• Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand held scanners.
  • Request assistance to bypass the security screener and advise the security staff that you have an implanted medical device. If you must proceed through the security screener, move through the security screener quickly and stay as far as allowed from the screener. Interference from these devices should not cause permanent damage to the implanted device.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft system that can broadcast a radio frequency (RF) signal. The high energy fields produced by these systems may interfere with the operation of the Remote Control or Therapy Controller and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as:
  • Wi_Fi routers
  • Cordless phones
  • Bluetooth® wireless streaming devices
  • Baby monitors
  • Microwave ovens

Note: When in close proximity, equipment that generates strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication between your Stimulator System. This may occur even if the equipment complies with International Special Committee on Radio Interference (CISPR) requirements.
Charging a Mobile Device with Therapy Controller App. Do not use the Therapy Controller App while the mobile device is charging. The effect of using the Therapy Controller App while charging the mobile device has not been evaluated.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Implantable Pulse Generators

• Patient should not charge while sleeping. This may result in a burn.
• While charging, the Charger may become warm. It should be handled with care.
• Failure to use the Charger with either the Charger Belt or an Adhesive Pad, may result in a burn. If pain or discomfort is felt, cease charging and contact Boston Scientific.

The Charger Base Station should be plugged in and the Charger placed in the Base Station when not in use. When the indicator light is green, the Charger is fully charged. When the indicator is amber, the Charger is partially charged, but is still able to deliver a charge to the IPG.

Boston Scientific Spinal Cord Stimulator Systems N/A
Bionic Navigator™ 3D System N/A
Bionic Navigator™ 3D 4.0 System N/A

Bionic Navigator™ 1.2 Software
Not Saving the current program or not performing one of the actions listed in footnote 1 immediately after clicking [OK] may result in the patient not feeling subsequent stimulation changes during the programming session, which may result in unintended over-stimulation.
Not Activating a program or not performing one of the actions listed in footnote 2 immediately after clicking [Delete] may result in the patient not feeling subsequent stimulation changes during the programming session, which may result in unintended over-stimulation.

Charger 2.0

• Do not charge while sleeping. This may result in a burn.
• While charging, the Charger may become warm. It should be handled with care.
• Failure to use the Charger with either the Charging Belt or an adhesive patch (available separately) may result in a burn. If you experience pain or discomfort, cease charging and contact Boston Scientific.

The Charging System for your Stimulator consists of the Charger unit, a Base Station, and a Power Supply. The Base Station is designed to remain connected to a power outlet at all times. When it is not being used, keep the Charger on the Base Station so that it is always ready to deliver a charge.

1. Find a convenient electrical outlet that meets the following criteria:
   •  will not expose the Charging System to water or direct heat
   •  next to a flat, clear surface for the Base Station
2. Plug the Power Supply into a standard AC wall outlet, and then plug the other end into the Base Station connector.
3. Place the Charger in the Base Station.

When charging, you must use the Charger with either the Charger Belt or an adhesive patch (available separately) to hold the Charger over the Stimulator. Before using the Charger Belt, refer to the instructions for using the Charger Belt in this manual. The adhesive patches are made of non reactive material suitable for most sensitive skin types. Note: Boston Scientific recommends the use of the Charger Belt for charging.

Freelink™ Remote Control
Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in unintended stimulation, Stimulator malfunction, and patient harm.
Always check the Stimulator battery to ensure that it is fully charged before performing a scan on the patient.
Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.
An MRI scan is not recommended when the impedances are not within the acceptable range. Higher or lower than normal impedances could indicate compromised Stimulator-Lead integrity. Scanning under these conditions may increase the risk of potential adverse effects that are listed in the “Safety Information” section of the ImageReady Full Body MRI Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems.

Surgical Leads N/A

Avista™ MRI xx cm 8 Contact Lead Kit
If the patient receives an MRI scan, broken conductor wires and damage to the lead body could increase the risk of tissue heating, which could cause tissue damage or serious patient injury.
The angle of the insertion needle should be 45° or less (Figure 4). Steep angles increase the insertion force of the stylet and also present more of an opportunity for the stylet to pierce the lead and cause tissue damage.
Do not abandon leads or any portion of leads or extensions in the patient when changing components or permanently explanting the IPG. Abandoned components may prevent the patient from being allowed MRI scans in the future due to concerns of lead electrode heating that can result in tissue damage.
Do not exchange the lead stylet while the electrode array of the lead is in the bevel of the insertion needle. If the electrode array is in the bevel area, remove the lead from the insertion needle before exchanging the stylet. Inserting the lead stylet in the lead while the electrode array is in the bevel of the insertion needle increases the risk of lead and tissue damage.
If the lead stylet is removed and reinserted, do not use excessive force when inserting the stylet into the lead. The use of instruments, such as forceps, to grasp the stylet during insertion is not recommended as this could result in applying excessive force and could increase the risk of lead and tissue damage.
Physicians should not prescribe MRI for patients undergoing trial stimulation or who have any SCS system components that are not fully implanted. Explant all trial stimulation components if an MRI scan is required. MRI has not been tested on trial stimulation components and may cause heating of the lead electrodes, resulting in tissue damage or serious patient injury.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
MRI procedures should be performed using ONLY a 1.5T or 3T horizontal closed bore MRI systems. Do not use MRI systems that are open-sided, vertical-field, or are operating at other static magnetic field strengths. The risks of using these MRI systems have not been determined and could be significant.
The Boston Scientific SCS System can be “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in this manual.
Apply the required B1+rms (or SAR) limit in the Normal Operating Mode. Do not conduct MRI scans in the First Level or Second Level Controlled Operating Modes as it may increase the risk of unintended stimulation and excessive heating.
The Boston Scientific SCS Systems with ImageReady MRI Technology have been shown through non-clinical testing to minimize the potential interactions with MRI when the appropriate conditions described in this manual are followed. For 1.5T Scanning. Only use 1.5T Full Body transmit/receive, Head transmit/receive, or Lower extremity transmit/receive coils. Circular Polarized (CP) only. Hydrogen/proton imaging only. Do not use other transmit/receive coils (e.g. linear coils). Local receive-only coils may be used.
For 3T Scanning. Only use Head transmit/receive, or Lower extremity transmit/receive coils. Circular Polarized (CP) only. Hydrogen/proton imaging only. Do not use Full Body transmit/receive or non-volume transmit/receive coils. Gradient Systems. Do not use gradient systems producing gradient slew rates per axis greater than 200 T/m/s, because they have not been tested and could cause increased risk of induced stimulation (resulting in shocking or jolting sensations, discomfort, or pain for the patient) or warming of the neurostimulator.
MRI Mode. MRI Mode must be enabled on the Stimulator before performing an MRI scan. Performing an MRI scan without MRI Mode enabled may lead to unintended stimulation, Stimulator malfunction, and patient harm.
Impedance Out of Range. Higher or lower than normal impedances could indicate compromised Stimulator-Lead integrity. Scanning under these conditions may increase the risk of potential adverse events listed in “Potential Adverse Events from MRI Interactions”.

• If the MRI targeted image area is near the neurostimulator, it may be necessary to move the neurostimulator to obtain an image, or use alternate imaging techniques. MRI images may be severely distorted or image target areas can be completely blocked from view near the implanted neurostimulation system components, especially near the neurostimulator.
• If the neurostimulator is removed, remove the entire neurostimulation system. Do not remove the neurostimulator and leave the Lead system implanted as this can result in higher than expected Lead heating under MRI exposure. Testing has not been completed to demonstrate safety of this configuration under MRI exposure. Excessive heating can result in tissue damage or serious patient injury.

Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.
Always check the Stimulator battery to ensure that it is fully charged before performing a scan on the patient. An MRI scan is not recommended when the impedances are not within the acceptable range. Higher or lower than normal impedances could indicate compromised Stimulator‑Lead integrity. Scanning under these conditions may increase the risk of potential adverse events that are listed in “Potential Adverse Events from MRI Interactions”.
Always check the Stimulator battery to ensure it is fully charged before performing an MRI scan on the patient. Depending on the Stimulator battery level, it may take a few hours to fully charge the Stimulator. Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.

mySCS™ GOTherapy Controller App
Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.
MRI scan is not recommended when the impedances are not within the acceptable range. Higher or lower than normal impedances could indicate compromised Stimulator-Lead integrity. Scanning under these conditions may increase the risk of potential adverse effects that are listed in the “Safety Information” section of the ImageReady MRI Guidelines referenced in the previous paragraph.
Always check the Stimulator battery to ensure it is fully charged before performing an MRI scan on the patient. Depending on the Stimulator battery level, it may take a few hours to fully charge the Stimulator.
Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.

Precision™ Adapter S8

• Precision™, Precision Spectra™, Precision Novi™, Precision™ Montage™, and Spectra WaveWriter™ Systems have not been evaluated for MRI scanning with Adapter S8. MRI scanning under conditions different than those in the labeling can result in severe patient injury.
• The Trial versions of the S8 Adapters are not MR conditional. MRI scanning under conditions different than those in the labeling can result in severe patient injury.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters
MRI procedures should be performed using ONLY a 1.5T horizontal closed bore MRI system. Do not use MRI systems that are open-sided, vertical-field, or are operating at other static magnetic field strengths. The risks of using these MRI systems have not been determined and could be significant.
The WaveWriter Alpha SCS System with Adapters can be “Full Body MR Conditional” only when exposed to the MRI environment under the specific conditions defined in this manual.
Apply the required B1+rms (or SAR) limit in the Normal Operating Mode. Do not conduct MRI scans in the First Level and Second Level Controlled Operating Modes as it may increase the risk of unintended stimulation and excessive heating.

• If the MRI targeted image area is near the neurostimulator, it may be necessary to move the neurostimulator to obtain an image, or use alternate imaging techniques. MRI images may be severely distorted or image target areas can be completely blocked from view near the implanted neurostimulation system components, especially near the neurostimulator.
• If the neurostimulator is removed, remove the entire neurostimulation system. Do not remove the neurostimulator and leave the Lead system implanted as this can result in higher than expected Lead heating under MRI exposure. Testing has not been completed to demonstrate safety of this configuration under MRI exposure. Excessive heating can result in tissue damage or serious patient injury.

Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction. Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or device malfunction.
Always check the Stimulator battery to ensure that it is fully charged before performing a scan on the patient.
An MRI scan is not recommended when the impedances are not within the acceptable range. Higher or lower than normal impedances could indicate compromised Stimulator-Lead integrity. Scanning under these conditions may increase the risk of potential adverse events listed in “Potential Adverse Events from MRI Interactions”.
The WaveWriter Alpha Systems with ImageReady MRI Full Body Technology have been shown through non-clinical testing to minimize the potential interactions with MRI when the appropriate conditions described in this manual are followed. Only use 1.5T Full Body transmit/receive, Head transmit/receive, or Lower extremity transmit/ receive coils. Circular Polarized (CP) only. Hydrogen/proton imaging only. Do not use other transmit/ receive coils (e.g. linear coils). Local receive-only coils may be used. Only 1.5T coils have been evaluated. Gradient Systems. Do not use gradient systems producing gradient slew rates per axis greater than 200 T/m/s, because they have not been tested and could cause increased risk of induced stimulation (resulting in shocking or jolting sensations, discomfort, or pain for the patient) or warming of the neurostimulator. MRI Mode. MRI Mode must be enabled on the Stimulator before performing an MRI scan. Performing an MRI scan without MRI Mode enabled may lead to unintended stimulation, Stimulator malfunction, and patient harm. Impedance Out of Range. Higher or lower than normal impedances could indicate compromised Stimulator-Lead integrity. Scanning under these conditions may increase the risk of potential adverse effects listed under “Potential Adverse Events from MRI Interactions”.

Precision™ Adapter M8

• Precision™, Precision Spectra™, Precision Novi™, Precision™ Montage™, and Spectra WaveWriter™ Systems have not been evaluated for MRI scanning with Adapter M8. MRI scanning under conditions different than those in the labeling can result in severe patient injury.
• The Trial versions of the M8 Adapters are not MR conditional. MRI scanning under conditions different than those in the labeling can result in severe patient injury.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device:

lithotripsy

electrocautery (See “Instructions for the Physician” on page 10)

external defibrillation

radiation therapy (Any damage to the device by radiation may not be immediately detectable.)

ultrasonic scanning

high-output ultrasound

X- ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT Scans are unlikely to damage the Stimulator if stimulation is turned off.
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on page 10. Ultimately, however, the device may require explantation as a result of damage to the device.
Subperception Therapy. Subperception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Full stimulation parameter ranges and options for both paresthesia-based and subperception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.
Automobiles and Other Equipment. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For these patients, any sudden stimulation changes may distract patients from proper operation of the vehicle, machinery, or equipment. For therapy that does not generate paresthesia (e.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment.
Post Operative. During the two weeks following surgery, it is important that patients use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions:

• Patients should not lift objects of more than 2.5 kg (5 lb).
• Patients should not engage in rigorous physical activity such as twisting, bending, or climbing.
• If new leads were implanted, patients should not raise their arms above their head.

Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients should be instructed that if discomfort continues beyond two weeks, they should contact their healthcare provider.
If patients notice excessive redness around the wound areas during this time, they should contact their healthcare provider to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their healthcare provider before making lifestyle changes due to decreases in pain.
Stimulator Orientation. Patients should never attempt to change the orientation of the Stimulator or turn over the Stimulator. Patients should avoid touching the incisions or Stimulator site. If the Stimulator f lips over in the Patient’s body, it may be unable to communicate with the Remote Control or Clinician Programmer. If the rechargeable Stimulator flips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator may become very thin over time. If this occurs, Patients should contact their healthcare provider.
Lead Location. In some instances a lead can move from its original location, and stimulation at the intended pain site can be lost. If this occurs, Patients should consult their healthcare provider who may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning the lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of battery functionality, or lead breakage. If the device stops working even after complete charging (up to four hours), Patients should turn off the Stimulator and contact their healthcare provider so that the system can be evaluated.
Operating Temperature. The operating temperature of the ETS and Remote Control is 5 to 40 °C (41 to 104 °F). For proper operation, do not use the Charger if the ambient temperature is above 35 °C (95 °F). Non-rechargeable IPGs will enter storage mode if its temperature falls below 8 °C. When the IPG is in storage mode, it will not connect to a Remote Control or Clinician Programmer. To exit storage mode, increase the IPG temperature above 8 °C.
Storage, Handling and Transport. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat.
If the Remote Control or the Charging System is to be stored for a period of time without batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system external components and accessories with care. Do not drop them or submerge them in water. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.) Upon completion of the Patient Trial, remove the batteries from the ETS.
Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The IPG should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Patients should contact their healthcare provider.
Remote Control, Charging System, and External Trial Stimulator Cleaning. The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control and ETS can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from soapy detergents should be removed with a cloth lightly dampened with water. Do not use abrasive cleansers for cleaning. Cleaning wipes for the External Trial Stimulator can also be ordered through Boston Scientific customer service. As an operator of the external devices, perform only the following service and maintenance tasks on the external devices:

• Changing the battery
• Charging the battery
• Cleaning

Ensure that the devices are not in use while performing service and maintenance tasks. Do not clean any of the accessories while they are directly or indirectly connected to a power outlet.
Cell Phones and Other Portable RF Communication Devices. While interference caused by cell phones is not anticipated, the full effects of interaction with cell phones are unknown at this time. Patients should be instructed that portable RF communications equipment (for example, mobile phones) should be kept a minimum distance of 6 inches (15 cm) from the area of the implanted device. If interference does occur, move the cell phone away from the Stimulator or turn off the phone. If there is a concern or a problem is encountered, patients should contact their healthcare provider.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Patients
Medical Devices/Therapies. The following medical therapies or procedures, especially if they are used near the Stimulator, may:

• Turn stimulation off.
• Cause permanent damage to the Stimulator.

Medical Therapies:

• lithotripsy — high-output sound or shock waves often used to treat gall stones and kidney stones
• electrocautery — the use of a heated electric probe to stop bleeding during surgery
• external defibrillation — the use of electrically charged paddles to restart the heart in an emergency
• radiation therapy — ionizing energy commonly used to treat cancer. Any damage to the device by radiation may not be immediately detectable.
• ultrasonic scanning — very high frequency sound waves used to produce images of internal organs or tissue for diagnostic purposes
• high-output ultrasound — high frequency sound waves which may be applied as physical therapy to treat certain bone/muscle injuries, or for muscle stimulation, or to improve blood flow
• X-ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT Scans are unlikely to damage the Stimulator if stimulation is turned off.

Before having procedures, medical therapies, or diagnostics, have your healthcare provider call our Customer Service department for instructions. Refer to “Contacting Boston Scientific” in this manual for contact information.
Subperception Therapy. Subperception stimulation is safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months.
Automobiles and Other Equipment. If you are using therapy that generates paresthesia you should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation turned on. Stimulation must be turned off first in such cases. Any sudden stimulation changes may distract you from proper operation of the vehicle, machinery, or equipment. For therapy that does not generate paresthesia (i.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicle, machinery, and equipment.
Post Operative. Always follow your healthcare provider’s guidance. After surgery, use care so that healing secures the implanted components and closes the surgical incision.

• Do not lift objects of more than 2.5 kilograms (five pounds).
• Do not engage in harsh physical activity such as twisting, bending, or climbing.
• Do not raise your arms above your head when new Leads are implanted.
• Do not pull or jiggle the Leads during the patient trial.

There may be some pain around the implant as the incisions heal. If pain continues beyond two weeks, contact your healthcare provider.
If you notice excessive redness around the wound areas, contact your healthcare provider. In rare cases, adverse tissue reaction to implanted materials can occur during this period.
Consult your healthcare provider before making any lifestyle changes due to decreases in pain.
Stimulator Position. Do not flip or change the position of the Stimulator. Avoid touching the incisions or Stimulator site. If the Stimulator flips over in your body:

• The Stimulator may lose communication with the Remote Control, Therapy Controller, or Clinician Programmer.
• The Stimulator cannot be charged.

If you notice a change in appearance of the skin over the Stimulator, such as the skin becoming thin over time, contact your healthcare provider.
Lead Location. In some cases, a Lead can move from its original location. If a Lead moves, stimulation at the intended pain site can be lost. If this occurs, consult your healthcare provider. Your healthcare provider may be able to restore stimulation by:

• Changing the programming of the Stimulator in the clinic.
• Changing the position of the Lead during another surgery.

Device Failure. Implants can fail at any time due to:

• Random component failure
• Loss of battery functionality
• Lead breakage

If the device stops working even after complete charging (up to four hours), turn off the Stimulator and contact your healthcare provider so that the system can be evaluated.

Operating Temperature. The operating temperature of the Trial Stimulator and Remote Control is 5 to 40 °C (41 to 104 °F). For proper operation, do not use the Charger (for rechargeable Stimulators) if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. Do not expose the Remote Control or Charging System (for rechargeable Stimulators) components to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat. If the Remote Control or the Charging System is to be stored for a period of time, be careful that the storage temperature does not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system components and accessories with care. Do not drop them or submerge them in water. Avoid all sources of water which can come into contact with the devices. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage the components. Refer to the Limited Warranty for additional information.
Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The Stimulator should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Please contact your healthcare provider for information.
Remote Control, Charging System and External Trial Stimulator Cleaning.
The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control and External Trial Stimulator can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from soapy detergents should be removed with a cloth lightly dampened with water. Do not use abrasive cleansers for cleaning. Do not clean any of the accessories while they are directly or indirectly connected to a power outlet.
As an operator of the external devices, you should perform only the following service and maintenance tasks on the external devices:

• Changing the battery
• Charging the battery
• Cleaning

Ensure that the devices are not in use while performing service and maintenance tasks.
Cell Phones and Other Portable RF Communication Devices. Interference caused by cell phones is not anticipated, but the full effects of interaction with cell phones are unknown at this time. Portable RF communications equipment (for example, mobile phones) should be kept a minimum distance of 6 inches (15 cm) from the area of the implanted device. If interference does occur, move the cell phone away from the Stimulator or turn off the phone. If there is a concern or a problem is encountered, contact your physician.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Implantable Pulse Generators
To allow a patient full-body MRI scan eligibility under specific conditions, implant a Boston Scientific SCS System with ImageReady MRI Technology as described below. If the implant conditions are not met, the patient will not have an SCS system with full-body MRI scan eligibility. MRI scans performed under different implant conditions can result in patient injury or damage to the implantable device.
Do not use polypropylene sutures as they may damage the Suture Sleeve. Do not suture directly onto the Lead, or use a hemostat on the Lead body. This may damage the Lead insulation. In addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.
Do not tunnel the Splitter.
Ensure that the Lead is fully inserted before tightening the Setscrew to prevent Lead damage. Do not Suture through the Leads or Splitter.
Tightening Sutures directly on the Lead can damage the Lead. In addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.
Tightening Sutures directly on the Lead can damage the Lead. In addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.

Boston Scientific Spinal Cord Stimulator Systems N/A

Bionic Navigator™ 3D System
Use the Bionic Navigator 3D 4.1 System with only WaveWriter Alpha™, WaveWriter Alpha™ Prime, Spectra WaveWriter, Precision Montage MRI, Precision Novi, and Precision Spectra Systems. Failure to do so may result in the inability to program the Stimulator.
The CP is not equipment for the patient environment as defined by IEC 60601-1. The CP and the person using the CP should not be in contact with the patient while programming.
Note: See Surface Pro 3, Surface Pro 6, or Surface Pro 7 manuals at www.microsoft.com for additional instructions. If desired, an external monitor can be connected for easier viewing by multiple people.
If the Therapy Controller App or Remote Control is used to turn off stimulation therapy during programming, set the Therapy ON/OFF button on the CP to OFF before resuming programming. This will ensure that the CP is synchronized with the therapy status of the Stimulator.
If any other device is used to turn Therapy OFF during programming, turn the Therapy On/ Off Button on the CP to OFF before resuming programming. This will ensure that the CP is synchronized with the stimulation status of the Stimulator.

Bionic Navigator™ 3D 4.0 System
Use the Bionic Navigator 3D 4.0 System with only WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems. Failure to do so may result in the inability to program the Stimulator.
The CP is not equipment for the patient environment as defined by IEC 60601-1. The CP and the person using the CP should not be in contact with the patient while programming.
Note: See Surface Pro 3, Surface Pro 6, or Surface Pro 7 manuals at www.microsoft.com for additional instructions. If desired, an external monitor can be connected for easier viewing by multiple people.
If the Remote Control is used to turn off stimulation therapy during programming, set the Therapy ON/OFF button on the CP to OFF before resuming programming. This will ensure that the CP is synchronized with the therapy status of the Stimulator.
If any other device is used to turn Therapy OFF during programming, turn the Therapy On/Off Button on the CP to OFF before resuming programming. This will ensure that the CP is synchronized with the stimulation status of the Stimulator.

Charger 2.0

• Keep the charger and charging components dry. They should not be exposed to moisture.
• Do not connect the charger to any other device except to the Base Station provided with it.
• Keep the charger and charging components away from pets, pests and children to avoid damage to the devices

Freelink™ Remote Control

• Keep the RC dry. It should not be exposed to moisture.
• Do not connect the RC USB port to any other device except to the RC charger provided with it.
• Keep the RC away from pets, pests and children to avoid damage to the device.

The Charger and Remote Control are MR Unsafe and must not be brought into the MRI scanner room.
The Remote Control is MR Unsafe and must not be brought into the MRI scanner room.
Always place the RC in the Silicone Case so that the Therapy ON/OFF button is on the open side.

Surgical Leads
Do not use the Passing Elevator or Paddle Blank to clear scar tissue or open up a narrow spinal canal. Exerting excessive force may cause patient injury or breakage of the Passing Elevator.
Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture directly onto the lead or use a hemostat on the lead body. This may damage the lead insulation or result in lead fracture.
Tightening sutures directly on the lead can damage the lead.

Avista™ MRI xx cm 8 Contact Lead Kit
To allow a patient MRI scan eligibility under specific conditions, implant a Boston Scientific SCS System with ImageReady MRI Technology as described below. If the implant criteria are not met, the patient will not have an SCS system with MRI scan eligibility. MRI scans performed under different conditions can result in patient injury or damage to the implantable device.

• Use only ImageReady MRI SCS system components (for example, leads and IPGs) as specified in the ImageReady MRI Guidelines for your SCS System.

Note: Lead extensions or splitters are not MRI scan eligible.

• Implant the IPG in the upper buttocks or lower flank.
• Implant the lead in the epidural space.

Note: Retrograde lead placements have not been evaluated for MRI.

Use only an insertion needle provided by Boston Scientific. Other needles may damage the lead. The stamped number “14” on the needle hub (or the triangle on the hub of the curved Epimed needle, sold separately) corresponds to the orientation of the bevel, which must face up. Turning the bevel ventral (down) may result in lead damage. An angle of more than 45° increases the risk of lead damage.
If other lead electrode locations are used (for example, retrograde, head, or peripheral), MRI scan eligibility will be restricted. The patient will not be eligible for MRI scans.
Do not force the stylet into the lead.
Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture directly onto the lead, or use a hemostat on the lead body. This may damage the lead insulation. In addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.
Tightening sutures directly on the lead can damage the lead. In addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
The Remote Control is MR Unsafe and must not be brought into the MRI scanner room.
The Charger and Remote Control are MR Unsafe and must not be brought into the MRI scanner room.
The instructions in this manual apply only to the following:

• On-label indications (epidural placement) of the Boston Scientific SCS System. Other configurations have not been evaluated.
• A complete and functional Boston Scientific SCS System composed only of components listed in “Table 1. Components that are eligible for Boston Scientific SCS System with ImageReady MRI Technology” on page 4, including IPG, Leads, and surgical accessories.

This manual is a supplement to the Boston Scientific SCS System product manuals and focuses specifically on the use of 1.5T and 3T horizontal closed bore MRI systems for patients implanted with the Boston Scientific SCS System.

mySCS™ GOTherapy Controller App
The mobile device used with the Therapy Controller App is MR unsafe and must not be taken inside the scan room.

Precision™ Adapter S8
Inspect the condition of the sterile package before opening the package and using the contents. Do not use the contents if the package is broken or torn, or if contamination is suspected because of a defective sterile package seal. Do not reuse, reprocess, or resterilize.

• Do not use if the product is past the labeled expiration date.
• Do not use if labeling is incomplete or illegible.
• Do not bend, kink, or stretch the Extension or Adapter; this may break its wires or connections. Broken wires or connections may create an open circuit, resulting in component failure, loss of stimulation, and potential surgical intervention.
• Do not retract the Setscrew completely as the Setscrew may fall out.
• Minimize the number of Hex Wrench insertions into the Precision Adapter S8 to prevent damage to the Septum.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters
The instructions in this manual apply only to the following:

• On-label indications (epidural placement) of the WaveWriter Alpha Spinal Cord Stimulator Systems. Other configurations have not been evaluated.
• A complete and functional WaveWriter Alpha System composed only of components listed in “Table 1. Components that are eligible for WaveWriter Alpha Systems with ImageReady MRI Full Body Technology with Adapters” on page 4, including IPG, Leads, Adapters, and surgical accessories.

The Remote Control is MR Unsafe and must not be brought into the MRI scanner room.
The Charger and Remote Control are MR Unsafe and must not be brought into the MRI scanner room.

Precision™ Adapter M8

• Inspect the condition of the sterile package before opening the package and using the contents. Do not use the contents if the package is broken or torn, or if contamination is suspected because of a defective sterile package seal. Do not reuse, reprocess, or resterilize.
• Do not use if the product is past the labeled expiration date.
• Do not use if labeling is incomplete or illegible.
• Do not bend, kink, or stretch the Extension or Adapter; this may break its wires or connections. Broken wires or connections may create an open circuit, resulting in component failure, loss of stimulation, and potential surgical intervention.
• Do not retract the Setscrew completely as the Setscrew may fall out.
• Minimize the number of Hex Wrench insertions into the Precision Adapter M8 to prevent damage to the Septum.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems
Potential risks are involved with any surgery.
The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include:

• Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.
• System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.
• Tissue reaction to implanted materials can occur. In some cases, the formation of reactive tissue around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological/sensory deficit, including paralysis. Time to onset is variable, possibly ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction and affect stimulation.
• Exposure to magnetic resonance imaging (MRI) can result in discomfort or injury due to heat near the Stimulator or the leads, tugging or vibration of the implanted system, induced stimulation, damage to the device requiring its replacement, and may distort the image needed for diagnosis.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure.
• The patient may experience painful electrical stimulation of the chest wall as a result of stimulation of certain nerve roots several weeks after surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or lead site.

In any event, instruct the patient to contact their healthcare provider to inform him/her.
Note: Diabetic patients may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in diabetic patients, particularly those with inadequate pre-operative glycemic control.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Patients
Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include:

• The Lead(s), which deliver stimulation, may move from their original implanted location. This may result in undesirable changes in stimulation and subsequent reduction in pain relief.
• System failure can occur at any time due to random failure(s) of the components or the battery. These events can result in ineffective pain control. These events may include:
  • Battery leakage
  • Device failure
  • Lead breakage
  • Hardware malfunctions
  • Loose connections
  • Electrical shorts
  • Open circuits
  • Lead insulation breaches
• Your body may react negatively to the materials used to manufacture the Stimulator or the leads. You may notice redness, warmth or swelling of the implant area. Tissue reaction to implanted materials can occur. In some cases, the formation of reactive tissue around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological/sensory deficit, including paralysis. Time to onset is variable, possibly ranging from weeks to years after implant.
• The skin over your implant may become thin and increasingly tender over time. A seroma may be formed.
• The most common surgical procedural risks are temporary pain at the implant site and infection. However, since the leads are placed in the epidural space, there is a small risk that spinal fluid may leak from the lead insertion site following surgery. Very rarely, you may develop an internal blood clot (hematoma) or blister (seroma); or you may experience epidural hemorrhage or paralysis. Your spinal cord may become compressed.
• External sources of electromagnetic disturbance may cause the device to malfunction and affect stimulation.
• Exposure to MRI can result in discomfort or injury due:
  • Heat near the Stimulator or the Leads.
  • Tugging or vibration of the implanted System.
  • Induced stimulation.
  • Damage to the device requiring its replacement.
• This may distort the image needed for diagnosis.
• Undesirable stimulation may occur over time due to:
  • Cellular changes in tissue around the electrodes.
  • Changes in electrode position.
  • Loose electrical connections and/or Lead failure.
• You may experience painful electrical stimulation of your chest wall as a result of stimulation of certain nerve roots several weeks after surgery.
• Over time, your implant may move from its original position.
• You may experience weakness, clumsiness, numbness or pain below the level of the implant.
• You may experience persistent pain at the Stimulator or lead site.
• Changes in blood glucose levels in response to any adverse event.

In any event, you should contact your physician and inform him/her.
Note: Diabetic patients may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in diabetic patients, particularly those with inadequate pre-operative glycemic control.

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Implantable Pulse Generators N/A
Boston Scientific Spinal Cord Stimulator Systems N/A
Bionic Navigator™ 3D System N/A
Bionic Navigator™ 3D 4.0 System N/A
Bionic Navigator™ 1.2 N/A
Charger 2.0 N/A
Freelink™ Remote Control N/A
Surgical Leads N/A
Avista™ MRI xx cm 8 Contact Lead Kit N/A

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
Potential Adverse Events from MRI Interactions. During an MRI examination there are potential interactions with the system that may result in heating, magnetic field effects, induced stimulation, undesired stimulation, or damage to the device. Damage to the device may result in inadequate stimulation or require device replacement. Following the safety conditions designated in this manual will minimize potential interactions described in this section.

• Heating – The MRI fields may interact with the Boston Scientific SCS System causing warming of the IPG and Leads. This may cause discomfort and pain.
• Mechanical effects: The MRI magnetic field may exert force or torque on the Boston Scientific SCS System. Patients may feel a tugging or vibration sensation. Patients with recent implant incisions may feel surgical wound discomfort.
• Induced stimulation: An MRI may induce energy onto the implanted Leads, potentially causing unintended or uncomfortable sensations (e.g., tingling, shocking, or jolting).

If these interactions cause the patient discomfort, stop the MRI scan.
Misuse. If an MRI scan is performed outside of the conditions advised in this manual (MRI scan not performed in accordance with MR conditional labeling), it may increase the risks of the potential interactions described above or result in more serious risks. These may include unintended stimulation, pain, tissue damage, burns, nerve injury, and paralysis.
Body Temperature. The MR Conditional evaluation has been performed for patients with a typical body temperature of 37°C. Elevated body temperature in conjunction with tissue heating caused by an MRI scan increases the risk of excessive tissue heating, which could cause tissue damage.
No Blankets. Do not cover the patient with blankets or heated blankets. Blankets raise the patient’s body temperature and increase the risk of tissue heating, which could cause tissue damage.
Patient Positioning. Only place the patient in the prone or supine position. Do not position the patient in other positions, e.g., on his or her side (called the lateral decubitus position) within the MRI bore. Scanning patients in positions other than prone or supine has not been evaluated and could cause excessive tissue heating during an MRI scan.
External Devices. External components (i.e., External Trial Stimulator and OR Cables, Remote Control and accessories, mobile device with Therapy Controller App, and Charger) are MR Unsafe. They must not be taken into any MR environment such as the MRI Scanner Room.
Supervision. A person with expert knowledge about MRI must ensure all procedures in this manual are followed and that the MRI scan parameters during both the pre-scan and the actual MRI examination are within the recommended settings listed in this manual.

mySCS™ GOTherapy Controller App N/A
Precision™ Adapter S8 N/A

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems with Adapters
Potential Adverse Events from MRI Interactions. During an MRI examination there are potential interactions with the system that may result in heating, magnetic field effects, induced stimulation, undesired stimulation, or damage to the device. Damage to the device may result in inadequate stimulation or require device replacement. Following the safety conditions designated in this manual will minimize potential interactions described in this section.

• Heating – The MRI fields may interact with the Boston Scientific SCS System causing warming of the IPG and Leads. This may cause discomfort and pain.
• Mechanical effects: The MRI magnetic field may exert force or torque on the Boston Scientific SCS System. Patients may feel a tugging or vibration sensation. Patients with recent implant incisions may feel surgical wound discomfort.
• Induced stimulation: An MRI may induce energy onto the implanted Leads, potentially causing unintended or uncomfortable sensations (e.g., tingling, shocking, or jolting).

If these interactions cause the patient discomfort, stop the MRI scan.
Misuse. If an MRI scan is performed outside of the conditions advised in this manual (MRI scan not performed in accordance with MR conditional labeling), it may increase the risks of the potential interactions described above or result in more serious risks. These may include unintended stimulation, pain, tissue damage, burns, nerve injury, and paralysis.
Body Temperature. The MR Conditional evaluation has been performed for patients with a typical body temperature of 37°C. Elevated body temperature in conjunction with tissue heating caused by an MRI scan increases the risk of excessive tissue heating, which could cause tissue damage.
No Blankets. Do not cover the patient with blankets or heated blankets. Blankets raise the patient’s body temperature and increase the risk of tissue heating, which could cause tissue damage.
Patient Positioning. Only place the patient in the prone or supine position. Do not position the patient in other positions, e.g., on his or her side (called the lateral decubitus position) within the MRI bore. Scanning patients in positions other than prone or supine has not been evaluated and could cause excessive tissue heating during an MRI scan.
External Devices. External components (i.e., External Trial Stimulator and OR Cables, Remote Control and accessories, mobile device with Therapy Controller App, and Charger) are MR Unsafe. They must not be taken into any MR environment such as the MRI Scanner Room.
Supervision. A person with expert knowledge about MRI must ensure all procedures in this manual are followed and that the MRI scan parameters during both the pre-scan and the actual MRI examination are within the recommended settings listed in this manual.

Precision™ Adapter M8 N/A