Indications, safety, and warnings for Spinal Cord Stimulator Systems

Indications for Use

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.

Refer to the Information for Prescribers manual for your SCS system for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientific, information regarding the Patient Identification card, FCC rules and clinical studies supporting clinical use of the neuromodulation system.

 

For other device-specific information not included in this manual, labeling symbols, and warranty information, refer to the appropriate Instructions for Use for your SCS System as listed on your Reference Guide.

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 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.

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.

 

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.

 

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.

 

Percutaneous Leads

The angle of the insertion needle should be 45° or less. 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 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.

The angle of the insertion needle should be 45° or less. 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 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.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord
Stimulator Systems

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.

If an MRI scan is performed in a condition other than advised in the MR Conditions of Use section it may result in serious risks, such as tissue damage or severe patient injury.

Only use 1.5T Full Body transmit/receive, Head transmit/receive, or 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 Interactions with MRI Environment.”

Potential Interactions with MRI Environment: During an MRI examination there are potential interactions with the system that may result in heating, magnetic field effects, induced stimulation, or damage to the device, requiring its 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 Spinal Cord Stimulator System causing warming of the IPG and Leads. This may cause discomfort, pain, or burns.
• Mechanical effects: The MRI magnetic field may exert force or torque on the Spinal Cord Stimulator 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.

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, and Battery 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.

• 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.

The WaveWriter Alpha SCS System 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.

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 effects listed in the “Safety Information” section under “Potential Interactions with MRI Environment.

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 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 Clinician Trial

OR Cable Description

Do not immerse the OR Cable or Extension in water or other liquids. The OR Cable and Extension are intended for one-time only use; do not resterilize.

• Keep the Trial Stimulator dry. It should not be exposed to moisture.
• Do not connect the Trial Stimulator to any other device except to the OR Cables provided with it.
• Keep the Trial Stimulator away from pets, pests, and children to avoid damage to the device.

Always turn the Trial Stimulator off and decrease the strength of stimulation to zero before connecting or disconnecting the OR Cable or OR Cable Extension.

 

Bionic Navigator™ 3D 4.0 System Programming

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.

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.

 

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.

 

Percutaneous Leads

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.

Do not insert or reinsert the needle stylet, LOR adaptor, or slotted needle into the sheath while the sheath is insert ed within the patient.

Do not bend the Entrada needle. Bending the Entrada needle may cause the stylet or LOR adapter to become jammed in the needle assembly and difficult to remove.

Use only an Entrada Needle provided by Boston Scientific. Other needles may damage the lead. Turning the bevel ventral (down) may result in lead damage. An angle of more than 45° increases the risk of lead damage.

Do not force stylet into lead.

Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture directly onto the lead, splitter, or use a hemostat on the lead body. This may damage the lead insulation.

Tightening sutures directly on the lead can damage the lead.

Do not tunnel splitter.

Tightening sutures directly on the lead can damage the lead.

 

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems

The instructions in this manual apply only to the following:

• On-label indications (epidural placement) of the WaveWriter Alpha Spinal Cord Stimulator System. 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 System with ImageReady MRI Full Body Technology” on page 4, including IPG, leads, and surgical accessories.

The instructions in this manual apply only to the following:

• On-label indications (epidural placement) of the WaveWriter Alpha Spinal Cord Stimulator System. 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 System with ImageReady MRI Full Body Technology” on page 4, including IPG, leads, 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.

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.