Indications, safety, and warnings for Vercise™ Deep Brain Stimulation Systems

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

Indications for Use

The Boston Scientific DBS System is indicated for use in the following:

• Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
• Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
• Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
• Bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

Intended Use

The intended use of the Boston Scientific DBS System is to treat movement disorders by stimulating a specific brain target.

Vercise™ Deep Brain Stimulation Systems Controller

The Vercise™ DBS Controller is intended to communicate with and control the compatible Boston Scientific Stimulator.

The Pairing Magnet is intended to initiate pairing of a compatible Boston Scientific Implantable Pulse Generator with a Clinician Programmer, Remote Control, or Controller.

Vercise™ Deep Brain Stimulation Systems Surgical Implant

• The Leads are medical devices that are intended to deliver stimulation from the compatible Boston Scientific Stimulator to a brain target.
• The Lead Extensions are intended to connect the Lead to the compatible Boston Scientific Implantable Pulse Generator (IPG).
• The Burr Hole Cover is intended to anchor implanted compatible Leads to the skull.
• The Boston Scientific Implantable Pulse Generator (IPG) is an implanted medical device intended to generate stimulation that is delivered via Leads to a brain target.
• The Port Plug is intended to close an unused port of the compatible Boston Scientific Implantable Pulse Generator (IPG) or Lead Extension.
• The Boston Scientific External Trial Stimulator (ETS) is an external medical device intended to generate stimulation that is delivered via Leads to a brain target.
• The Tunneling Tool is intended to create a subcutaneous path for tunneling the Lead to the Lead Extension and/or the Lead Extension to the IPG pocket.
• The Physician’s Spare Kit is intended to be an aid in implanting the Boston Scientific implantable medical devices.
  • The Lead Boot is intended to protect the proximal end of the implanted Lead/Lead Extension when it is not connected to an Implantable Pulse Generator (IPG).
  • The Lead Stop is intended to be temporarily fixed externally to the Lead to aid Lead placement at the desired depth.
  • The Hex Wrench is intended to be used to tighten or loosen a Setscrew (found in Adapters, Lead Extensions, Lead Boots, and IPGs).
  • Suture Sleeves are intended to anchor compatible Leads to appropriate tissue, or if a mini plate is used to secure the Lead, the Suture Sleeve is placed between the Lead and the mini plate to protect the Lead.
• The O.R. Cable is intended to connect the Lead to the ETS to facilitate stimulation testing.
• The External Trial Stimulator (ETS) Adapter is intended to connect the compatible O.R. Cable and Extension to the ETS during operating room test stimulation.

Vercise™ Neural Navigator 5 Software

The intended use of the Neural Navigator programming software on a Clinician Programmer platform is to set and adjust stimulation parameters for the compatible Boston Scientific Stimulator.

StimSearch Programming

The StimSearch Programming Assistant software is intended to be used as supporting software to optimize the process of selecting stimulation settings to try when programming compatible Boston Scientific Stimulators with the Vercise Neural Navigator programming software.

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

The Boston Scientific DBS System, or any of its components, is contraindicated for the following:

Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used on patients implanted with the Boston Scientific DBS System, or any of the system components. The energy generated by diathermy can be transferred to the Boston Scientific DBS System, causing tissue damage in the brain resulting in severe injury or death.

Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS): The safety of these therapies in patients implanted with the Boston Scientific DBS System has not been established. It is possible that the energy generated by these therapies can be transferred to the Boston Scientific DBS System, causing tissue damage that may result in severe patient injury or death.

Magnetic Resonance Imaging (MRI) (Vercise PC Only):  Patients implanted with the Vercise PC DBS System (DBS Leads, Lead Extensions, and Stimulator) should not be subjected to MRI. MRI exposure may result in the following:

• Dislodgement of implanted components.
• Heating of the Contacts or other system components, causing permanent tissue lesioning.
• Damage to the Stimulator’s electronics.
• Current induction through the DBS Leads and Vercise PC DBS System causing unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or death.

Note:  The Lead‑Only System (before Stimulator is implanted), the Vercise Gevia System, and the Vercise Genus System are MR Conditional. An MRI examination can be conducted safely when all the instructions in the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems are followed. For the latest version of the manual, go to www.IFU‑BSCI.com.

Patient Incapability: Patients who are unable to properly operate the Remote Control, Controller App, and/or Charging System should not be implanted with the Boston Scientific DBS System.

Poor Surgical Candidates: The Boston Scientific DBS System is not recommended for patients who are poor surgical candidates.

Unsuccessful Test Stimulation: The Boston Scientific DBS System should not be used in patients who experience unsuccessful test stimulation.

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

The following is a list of warnings that should be heeded when implanting or using the DBS Stimulator.

Automobiles and Equipment: Patients should operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with caution after receiving the Boston Scientific DBS System. Patients should avoid performing activities that would be dangerous if treated symptoms were to return, or in which stimulation changes could occur.

Charge Density: High levels of stimulation may damage brain tissue. To maintain safe limits, the DBS programming software will display a message when the stimulation level selected would exceed the safe limit, and programming of these settings will be prevented.

Patients may be granted the ability to change stimulation amplitude with the Remote Control or Controller App within clinician‑defined limits. The software prevents patient‑controlled amplitude from exceeding the limit.

Charging a Mobile Device with Controller App: Do not use the Controller App while the mobile device is charging. The effect of using the Controller App while charging the mobile device has not been evaluated.

DBS Extension Connector: Implanting the DBS Lead Extension Connector in the soft tissue of the neck may increase the chance of DBS Lead breakage. Boston Scientific recommends placing the DBS Lead Extension Connector behind the ear such that glasses or headgear do not interfere with the implanted DBS System.

Electromagnetic Interference: Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with Remote Control or mobile device communication. If an electromagnetic field is strong enough to turn stimulation off, this will be temporary and stimulation may automatically return once the electromagnetic field 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 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. Interference from these devices should not cause 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 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 or mobile device and its ability to control stimulation.
• For DBS devices not using Bluetooth technology for communication, other sources of electromagnetic disturbance, such as RF transmitters at television or radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service band transceivers.
• For DBS devices using Bluetooth technology for communication, other sources of electromagnetic disturbance, such as Wi‑Fi routers, cordless phones, Bluetooth wireless streaming devices, baby monitors, and microwave ovens.

Note: When in close proximity to them, equipment that generates strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with International Special Committee on Radio Interference (CISPR) requirements.

Heat Due to Charging: Patients should not charge while sleeping. This may result in a burn. The Charger may become warm while charging the Stimulator. The Charger should be handled with care. Failure to use the Charging Collar, Charger Belt, or an Adhesive Patch while charging, as directed, may result in a burn. If the patient experiences pain or discomfort, they should stop charging and contact their healthcare provider.

Intracranial Hemorrhage: Special precautions should be taken for patients who are prone to hemorrhage, including patients with coagulopathy, high blood pressure, or those who are using prescribed anticoagulants. Microelectrode penetration and DBS Lead insertion can put patients who have a likelihood of intracranial hemorrhages at greater risk.

Magnetic Resonance Imaging (MRI): The Vercise Genus and Vercise Gevia DBS Systems are “MR Conditional.” This means that an MRI examination can be conducted safely using a 1.5 Tesla horizontal closed bore MRI system when all instructions and safety information in the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems are followed.

The ImageReady™ MRI Guidelines for Boston Scientific DBS Systems manual appears on the Boston Scientific website www.IFU‑BSCI.com or may be provided in your region. It is important to read the information in this supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a Boston Scientific DBS System.

External Devices:The external/non‑implantable components of the Boston Scientific DBS System (External Trial Stimulator, ETS Adapter, O.R. Cables, Remote Control, mobile device with Controller App, Charging System, Clinician Programmer, Pairing Magnet, Programming Wand, and accessories) are MR Unsafe. They must not be taken into any MR environment such as the MRI scanner room.

Other Active Implantable Devices: Concurrent use of Stimulators such as the Boston Scientific DBS Stimulator and other active implantable devices, such as pacemakers, cardioverter defibrillators, or medication delivery pumps may result in interference with the operation of the devices. If the patient requires concomitant implantable active devices, careful programming of each system is necessary.

Pregnancy: It is unknown whether this device may cause complications with pregnancy and/or hurt an unborn baby.

Stimulator Damage: Chemical burns may result if the Stimulator housing is ruptured or pierced, exposing the patient’s tissue to battery chemicals. Do not implant the Stimulator if the housing is damaged.

Suicide: New onset or worsening depression which may be temporary or permanent is a risk that has been reported with DBS therapy.  Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Therefore, physicians should consider the following:

• Preoperatively, assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated.
• Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control.
• If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately.
• Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow‑up, including when to contact their healthcare provider.

Therapeutic Ultrasound: Implanted components of the Boston Scientific DBS System should not be exposed to therapeutic levels of ultrasound energy. The implanted device may concentrate the ultrasound field and may cause patient harm.

Unauthorized Modification: Unauthorized modification to the medical devices is prohibited. The integrity of the DBS System could be compromised and harm or injury to the patient could occur.

 

Vercise™ Deep Brain Stimulation Systems Controller

The Pairing Magnet has a strong magnetic field that may cause interference with devices that are sensitive to magnetic fields. For appropriate guidance, consult the instructions for use for these devices.

The Charger and the mobile device used with the Controller App are MR Unsafe and must not be brought into the MRI scanner room.

Do not perform an MRI scan if MRI Mode is not entered. Scanning under different conditions may result in patient injury or Stimulator malfunction.

Always check the rechargeable 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.

An MRI scan is not recommended when the impedances are not within the acceptable range except when scanning a Vercise Genus DBS Mixed M8 System or Vercise Genus DBS Mixed S8 System and Contacts 5, 6, 7, and 8 are out of range for the scan eligible Medtronic Leads. Refer to ImageReady™ MRI Guidelines for Boston Scientific DBS Systems before proceeding. Additionally, an MRI scan is not recommended when the impedances are not within the acceptable range except when scanning a System with a Port Plug in a Stimulator Port(s) or Lead Extension Port and all Contacts in the plugged Port are 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 that are listed in the “Safety Information” section of ImageReady™ MRI Guidelines for Boston Scientific DBS Systems under “Potential Interactions with MRI Environment.”

 

Vercise™ Deep Brain Stimulation Systems Surgical Implant

Before securing the Base of the Burr Hole Cover, examine the cranial bone and structure to ensure that disease or damage is not present and that the thickness of the cranial bone is 5 mm or greater. Failure to adhere to this warning may affect the following:

• Lead Anchoring: Lead migration due to an improperly anchored DBS Lead may diminish the effectiveness of therapy.
• Burr Hole Closure: An unstable burr hole closure may increase the risk of infection and place the patient at risk for damage to brain tissue, leakage of cerebrospinal fluid, and/or damage to the dura.

Always turn the ETS 3 off before connecting or disconnecting the O.R. Cable assemblies to prevent unexpected stimulation.

 High charge density can cause permanent tissue damage. The Clinician Programmer will limit stimulation parameters to safe values.

Increasing the number of Lead penetrations increases the probability of hemorrhage. To minimize acute Lead revisions, use techniques of target localization, such as microelectrode recordings and/or imaging.

 A sudden increase in stimulation may occur if ETS 3 is ON while disconnecting the O.R. Cables.

 Always turn the ETS 2 off before connecting or disconnecting the O.R. Cable assemblies to prevent unexpected stimulation.

A sudden increase in stimulation may occur if ETS 2 is ON while disconnecting the O.R. Cables.

Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG.

Be careful not to puncture or damage important structures along the tunneling path, such as the brachial plexus and jugular vein, as this may cause patient harm.

Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG.

Incorrect placement of the IPG in the pocket could require a revision surgery.

Avoid placing the excess length of the Lead Extensions on the superficial surface of the IPG as this may result in tissue erosion, ineffective communication, or charging difficulty.

When explanting the Boston Scientific DBS System, the DBS Lead should be pulled from the site behind the ear, and not the site near the burr hole, to avoid a potential spread of infection toward the incision on the skull.

The DBS Lead should be pulled from the site behind the ear, and not the site near the burr hole, to avoid a potential spread of infection toward the incision on the skull.

Avoid pulling towards the ear to reduce the potential for infection of the DBS Leads.

 

StimSearch Programming

The Pairing Magnet has a strong magnetic field that may cause interference with devices that are sensitive to magnetic fields. For appropriate guidance, consult the instructions for use for these devices.

Before securing the Base of the Burr Hole Cover, examine the cranial bone and structure to ensure that disease or damage is not present and that the thickness of the cranial bone is 5 mm or greater. Failure to adhere to this warning may affect the following:

• Lead Anchoring: Lead migration due to an improperly anchored DBS Lead may diminish the effectiveness of therapy.
• Burr Hole Closure: An unstable burr hole closure may increase the risk of infection and place the patient at risk for damage to brain tissue, leakage of cerebrospinal fluid, and/or damage to the dura.

Always turn the ETS 3 off before connecting or disconnecting the O.R. Cable assemblies to prevent unexpected stimulation.

High charge density can cause permanent tissue damage. The Clinician Programmer will limit stimulation parameters to safe values.

Increasing the number of Lead penetrations increases the probability of hemorrhage. To minimize acute Lead revisions, use techniques of target localization, such as microelectrode recordings and/or imaging.

A sudden increase in stimulation may occur if ETS 3 is ON while disconnecting the O.R. Cables.

Always turn the ETS 2 off before connecting or disconnecting the O.R. Cable assemblies to prevent unexpected stimulation.

A sudden increase in stimulation may occur if ETS 2 is ON while disconnecting the O.R. Cables.

Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG.

Be careful not to puncture or damage important structures along the tunneling path, such as the brachial plexus and jugular vein, as this may cause patient harm.

Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG.

Incorrect placement of the IPG in the pocket could require a revision surgery.

Avoid placing the excess length of the Lead Extensions on the superficial surface of the IPG as this may result in tissue erosion, ineffective communication, or charging difficulty.

Removing the DBS Leads

When explanting the Boston Scientific DBS System, the DBS Lead should be pulled from the site behind the ear, and not the site near the burr hole, to avoid a potential spread of infection toward the incision on the skull.

The DBS Lead should be pulled from the site behind the ear, and not the site near the burr hole, to avoid a potential spread of infection toward the incision on the skull.

Avoid pulling towards the ear to reduce the potential for infection of the DBS Leads.

ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

MRI System: Only use 1.5T Full Body transmit/receive (Circular Polarized (CP) Only), Head transmit/receive (Circular Polarized (CP) Only), or lower extremity transmit/receive (Circular Polarized (CP) Only) coils. Use 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.

Active Scan Time: Do not exceed cumulative active scan time (with RF On) of 30 minutes per imaging session. If 30 mins of active scan time is reached, allow 60 mins of non‑active time before proceeding. Exceeding the active scan time increases the risk of tissue heating.

MRI Scanner Operating Mode: Apply the required B1+rms/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 potential adverse effects listed below under “Potential Interactions with MRI Environment.”

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.

Impedances 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 implanted DBS System. Following the safety conditions designated in this manual will minimize the potential interactions described in this section.

• Heating – The MRI RF field interacts with the implanted system and can produce significant heating effects at the Lead‑electrode‑tissue and/or Stimulator‑tissue interface. This can cause tissue damage, discomfort, pain, inadequate stimulation, Stimulator malfunction, and/or the need for additional intervention.
• Main Magnetic Field Interactions – The MRI magnetic field may exert translation and torque effects on the implanted Lead and/or Stimulator. Patients may feel a tugging sensation, discomfort or pain at the site of the Lead or Stimulator implant. Patients with recent implant incisions may feel surgical wound discomfort.
• Induced Stimulation – An MRI may induce energy into the implanted Leads, potentially causing unintended or uncomfortable stimulation or unusual sensations.

If interactions occur and cause the patient discomfort, stop the MRI scan.

If an MRI scan is performed outside of the conditions advised in this manual, 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, edema, burns, nerve injury, cerebrovascular accidents, coma, paralysis, or death.

Gradient Systems: Do not use gradient systems producing gradient slew rates greater than 200 T/m/s because they have not been evaluated and could cause increased risk of induced stimulation.

Body Temperature: The MR Conditional evaluation has been performed for patients with a typical body temperature of 37 °C (98.6 °F). 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 (e.g., Charger, Remote Control, mobile device with Controller App, External Trial Stimulator, ETS Adapter, O.R. Cables, Clinician Programmer, Pairing Magnet, Programming Wand, and accessories) are MR Unsafe. They must not be taken into any MRI 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 prescan and the actual MRI examination are within the recommended settings listed in this manual.

The Charger, Remote Control, and mobile device used with the Controller App are MR Unsafe and must not be brought into the MRI scanner room.

Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or Stimulator malfunction.

Always check the Stimulator battery to ensure that it is fully charged before performing an MRI scan on the patient.

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

Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or Stimulator malfunction.

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

Do not perform an MRI scan if MRI Mode is not enabled. Scanning under different conditions may result in patient injury or Stimulator malfunction.

An MRI scan is not recommended when the impedances are not within the acceptable range except when scanning a Vercise Genus DBS Mixed M8 System or Vercise Genus DBS Mixed S8 System and Contacts 5, 6, 7, and 8 are out of range for the scan eligible Medtronic Leads. Additionally, an MRI scan is not recommended when the impedances are not within the acceptable range except when scanning a System with a Port Plug in a Stimulator Port(s) or Lead Extension Port and all Contacts in the plugged Port are 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 that are listed in the “Safety Information” section of this manual under “Potential Interactions with MRI Environment.”

Do not perform an MRI scan if MRI Mode is not entered. Scanning under different conditions may result in patient injury or Stimulator malfunction.

Always check the rechargeable 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.

The Charger and the mobile device used with the Controller App are MR Unsafe and must not be brought into the MRI scanner room.

Do not perform an MRI scan if MRI Mode is not entered. Scanning under different conditions may result in patient injury or Stimulator malfunction.

The Charger and the mobile device used with the Controller App are MR Unsafe and must not be brought into the MRI scanner room.

The mobile device used with the Controller App is MR Unsafe and must not be brought into the MRI scanner room.

Do not perform an MRI scan if MRI Mode is not entered. Scanning under different conditions may result in patient injury or Stimulator malfunction.

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

The following is a list of precautions that should be taken when implanting or using the DBS Stimulator.

Bathing: Patients should exercise reasonable caution when bathing.

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 in (15 cm) from the area of the implanted device. If interference does occur, move the cell phone away from the implanted Stimulator or turn off the phone. If there is a concern or a problem is encountered, patients should contact their healthcare provider.

Cleaning the Charger Belt or Charging Collar: Do not machine wash the Charger Belt or Charging Collar.

Cleaning the Mobile Device: For users of a mobile device, refer to the device manufacturer for more information.

Cleaning the Remote Control, External Trial Stimulator, Charger, Base Station, Power Supply, and Programming Wand: 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, perform only the following 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.

Component Removal, Disposal, and Return: Any explanted components should be returned to Boston Scientific. The Stimulator should be explanted in the case of cremation and returned to Boston Scientific. Cremation may cause the Stimulator battery to explode.

The Remote Control or Charger should not be disposed of in fire, as these devices contain batteries which may explode causing injury when exposed to fire. Used batteries should be disposed of in accordance with local laws and regulations.

Dispose of non‑implantable components and packaging in accordance with hospital, administrative, and/or local government policy. For users of a mobile device, refer to the device manufacturer for disposal information.

After use or in the case of explantation, devices may contain biohazardous substances. Devices that contain biohazardous substances are considered biohazardous waste and should be stored in a biohazard container that is labeled with the biological hazard symbol until disposed of in accordance with hospital, administrative and/or local government policy. Untreated biohazardous waste should not be disposed of in the municipal waste system. Alternatively, biohazardous waste may be disposed of utilizing a certified facility for biohazardous waste for proper treatment in accordance with hospital, administrative, and/or local government policy. Alternatively, if you would like to return this device to Boston Scientific Corporation, contact your sales representative for return instructions.

Components: The use of components other than those approved and/or supplied by Boston Scientific and intended for use with the Boston Scientific DBS System may damage the DBS System, diminish the effectiveness of therapy, and/or put the patient at unknown risk.

Connections: Before inserting any DBS Lead or DBS Lead Extension into any Connector or Header ports, including the Stimulator Header, DBS Lead Extension Connectors, and O.R. Cable Assembly, always wipe the DBS Lead with a sterile, dry cotton sponge. Contamination inside the Connector or Header ports may be difficult to remove and can cause high impedances, preventing electrical connectivity which may compromise the integrity of the stimulation circuit.

Device Connections: Do not connect the Remote Control USB port to any other device except to the Remote Control charger provided with it. Do not connect the Charger to any other device except to the Base Station provided with it. Do not connect the Programming Wand USB port to any other device except to the USB Cable provided with it.

For users of a mobile device, refer to the device manufacturer for more information.

Device Failure: Implants can fail at any time due to random component failure, loss of battery functionality, or DBS Lead breakage. Stopping brain stimulation suddenly can cause serious reactions to develop. If the Stimulator stops working, patients should be instructed to turn off the Stimulator and contact their healthcare provider immediately so that the system can be evaluated and appropriate medical care can be given to manage the return of symptoms.

Environmental Precautions: Patients should avoid activities that could potentially involve large amounts of electromagnetic interference. Devices that contain permanent magnets, such as speakers, should not be placed near the Stimulator because they may cause the DBS System to turn on or off.

Excess DBS Extension: Coil excess DBS Lead Extension around or below the Stimulator. Excess wire on top of the Stimulator may increase the potential for communication interference, tissue erosion, or damage during Stimulator replacement surgery.

Inspect Packaging Before Use: Check the expiration date on the package before opening the sterile package and using the contents. Do not use the contents if the current date is past the expiration date, if the package is opened or damaged, or if contamination is suspected because of a defective sterile package seal.

• Inspect the seal integrity of the outer tray before use.
• Open the inner tray in the sterile field.
• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged. Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation. Return the damaged Stimulator to Boston Scientific.
• Do not use any component that shows signs of damage.
• Do not use if “Use By” date has expired.

Massage Therapy: Patients should avoid receiving massage therapy near the implanted system components. If a patient does receive massage therapy, the patient should inform the massage therapist that they have an implanted device and show the massage therapist where the Stimulator, DBS Lead Extensions, and DBS Leads are located. The patient should advise the massage therapist to avoid these areas and proceed with caution.

Medical Devices/Therapies: The following medical therapies or procedures may turn stimulation off, cause permanent damage to the Stimulator, or may cause injury to the patient. If any of the procedures below is required by medical necessity, the procedure(s) should be performed as far from the implanted components as possible. Stimulator function should be confirmed after the procedure. Ultimately, however, the Stimulator may require explantation because of damage to the device or patient harm.

• Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is turned off. Testing has been completed to applicable standards.
• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads and/or Stimulator. See additional instructions below. Bipolar or monopolar electrocautery may be used. Electrocautery probes must be kept a minimum of 1 in (2.5 cm) away from the implanted device.
• External Defibrillation – Safe usage of external defibrillation has not been established in DBS patients. Defibrillation of the patient is unlikely to permanently damage the implanted device if stimulation is turned off and the defibrillator electrode does not come into contact with any component of the implantable device. Testing has been completed to applicable standards.
• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry. See additional instructions below.
• Radiation Therapy – Lead shielding should be used over the Stimulator to prevent damage from high radiation. Any damage to the device by radiation may not be immediately detectable.
• 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 the patient is required to undergo lithotripsy, electrocautery, external defibrillation, radiation energy, ultrasonic scanning, X‑ray, or CT scan, observe the following:

• If it is feasible given the patient’s clinical condition, turn off stimulation at least 5 minutes before the procedure application.
• All equipment, including probes, ground plates and paddles, must be used as far away from the Stimulator as possible and oriented such that energy is not directed through or across the Stimulator, Leads, or Lead Extensions.
• Every effort should be taken to keep fields, including current, radiation, or high‑output ultrasonic beams, away from the Stimulator.
• Equipment should be set to the lowest energy setting clinically indicated.
• Confirm the system is functioning properly following the procedure. Turn stimulation on and observe for the return of therapy to confirm functionality.

Operating Temperature: The operating temperature of the External Trial Stimulator, Remote Control, and Programming Wand is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not use the Charging System if the ambient temperature is above 35 °C (95 °F).

For users of a mobile device, refer to the device manufacturer for more information.

Other Models of External Devices: Only the Remote Control, Charging System (as applicable), Programming Wand, External Trial Stimulator, and Clinician Programmer that were provided with the Boston Scientific DBS System should be used with the Boston Scientific DBS System. Other models of these devices will not function with the Boston Scientific DBS System.

Only mobile devices that are compatible with the Controller App work with the Vercise Genus DBS System. Refer to the Controller IFU for more information.

Patient Activities Requiring Coordination: Loss of coordination is a potential side effect of DBS therapy. Patients should exercise reasonable caution when participating in activities requiring coordination, including those that they were able to perform prior to receiving DBS therapy (e.g., swimming).

Patient Activity Following Surgery: During the 2 weeks following surgery, it is important for the patient to exercise extreme care so that appropriate healing will secure the implanted components. During this period, the patient should not attempt to move heavy objects. Instruct the patient to restrict head movements, including extension or flexion of the neck and rotation of the head, until healing is complete.

Setscrews: Before tightening Setscrews, always test impedance to confirm electrical connectivity. Tightening a Setscrew onto a Lead Contact may damage the Contact and may result in the need to replace the DBS Lead or DBS Lead Extension.

Single Use Only, Do Not Resterilize: For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Products used during surgery and explanted components are biohazards.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Sterilization: Contents of the surgical kits are supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call Boston Scientific Technical Support and return the damaged part to Boston Scientific.

All implantable and surgical components are sterilized with EO and are for single use only.

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 use any component that shows signs of damage.
• Do not resterilize the package or the contents. Obtain a sterile package from Boston Scientific.
• Do not use if the product is past the labeled expiration date.
• All components are for single use only. Do not reuse.
• Do not use if the package is opened or damaged.
• Do not use if the labeling is incomplete or illegible.

Stimulator Orientation: Orient the Stimulator parallel to the skin surface. Suboptimal placement of the Stimulator may result in a revision surgery. Patients should avoid touching the Stimulator site or incisions. If patients notice a change in the appearance of the skin at the

Stimulator location, such as the skin becoming thin over time, they should contact their healthcare provider.

In order to ensure effective device communications, including device programming, and proper charging, perform the following:

• For rechargeable IPGs, orient the Stimulator parallel to the skin surface and at a depth less than 2 cm and greater than 0.5 cm below the skin.
• For non‑rechargeable Vercise Genus IPGs, orient the Stimulator parallel to the skin surface and at a depth less than 2.5 cm below the skin to ensure effective device communication.
• For the non‑rechargeable Vercise PC IPG (DB‑1140‑S), orient the Stimulator parallel to the skin surface. There is no depth restriction for the Vercise PC IPG.
• The etched writing “This Side Up” must be facing out of the pocket toward the patient’s skin.

Suboptimal placement of the Stimulator may result in the inability to communicate with the device or inability to recharge and may require a revision surgery.

Patients should be instructed not to change the orientation of or turn over the Stimulator. If the Stimulator flips over in the body, then it cannot communicate or be charged. If stimulation cannot be turned on after charging, the Stimulator may have changed orientation or rotated; patients should contact their healthcare provider to arrange an evaluation of the system.

Storage, Handling, and Transport: Implanted components, such as the Stimulator, Leads, Lead Extensions, and Adapters, have no special storage or handling requirements.

The non‑rechargeable Stimulator will enter storage mode if its temperature falls below 5 °C (41 °F). When the Stimulator is in storage mode, it will not connect to a Remote Control, Controller App, or Clinician Programmer. To exit storage mode, increase the Stimulator temperature above 8 °C (46 °F).

Store external components like the Remote Control, External Trial Stimulator, ETS Adapter, O.R. Cable and Extension (DB‑4100A), Programming Wand, and Charging System between ‑20 °C to 60 °C (‑4 °F to 140 °F). Store the Push‑Button O.R. Cables (DB‑4120‑08 and DB‑4120‑16) between 0 °C to 45 °C (32 °F to 113 °F). Do not expose the external 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.

Handle the system components and accessories with care. Do not drop them or submerge them in water. Avoid all sources of water that could 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. Keep the Remote Control and Charger away from pets, pests, and children to avoid damage to the devices.

Care must be taken to avoid damaging the DBS Lead with sharp instruments or excessive force during surgery. The following guidelines will help to ensure the longevity of components:

• Do not sharply bend or kink the DBS Lead or Lead Extension.
• Do not tie Suture(s) directly to the DBS Lead or Lead Extension body.
• Avoid pulling an implanted DBS Lead taut; stress relief loops may help to minimize tension on the DBS Lead.
• Avoid handling the DBS Lead with sharp instruments; use only rubber‑tipped forceps.
• Take care when using sharp instruments, such as hemostats or scalpels, to prevent damaging the DBS Lead.

For users of a mobile device, refer to the device manufacturer for more information.

Surgical Tape: If tape is used to temporarily secure the DBS Lead during surgery, caution should be used to ensure the Lead is not cut or damaged when removing the tape.

Sutures: Do not apply Sutures tightly around the DBS Leads, as this may damage the insulation of the DBS Lead and may result in DBS Lead failure.

Tissue Reaction: Temporarily, there may be some pain in the area of the Stimulator as the incisions heal. If there is excessive redness around the wound area, it should be checked for infection. In rare cases, adverse tissue reaction to implanted materials can occur.

Be careful when using sharp surgical tools around the DBS Lead to avoid nicking or damaging the DBS Lead. A damaged DBS Lead can result in intermittent or loss of stimulation, requiring surgical replacement or revision.

Do not immerse the O.R. Cable Connector or plug in water or other liquids. The O.R. Cable is intended for single use only; do not resterilize.

While securing the DBS Lead, use care not to impact its implanted location.

Securing the DBS Lead with a mini plate without a Suture Sleeve may damage the DBS Lead and require a surgical replacement or revision.

Do not adjust the horseshoe end of the Placement/Removal Tool after the Retaining Clip has been attached.

Do not reinsert the Lead Stylet into the DBS Lead while the DBS Lead is in the brain, as this may damage the DBS Lead and/or cause patient harm.

While removing or releasing the DBS Lead from the instrumentation (e.g., Cannula, Microdrive), use care not to bend the proximal array of the DBS Lead. If the proximal array is bent during removal from the instrumentation, the DBS Lead may be damaged.

Secure the DBS Lead using a Lead Exit Slot that is approximately perpendicular to the Retaining Clip channel.

Do not use the 8 Contact Lead Boot on a 16 Contact Lead. Do not use the 16 Contact Lead Boot on an 8 Contact Lead. Make sure to use the Lead Boot provided in the Lead Kit or appropriate Physician’s Spare Kit. The Lead Boot length is different for 8 and 16 Contact Leads.

The Hex Wrench is torque‑limiting to prevent overtightening of the Setscrew. Use only the Hex Wrench provided, as other tools may overtighten the Setscrew and damage the DBS Lead.

Placement of the Lead Extension Connector in the neck region can increase the risk of device failure due to repetitive movement of the neck.

Performing blunt dissection with the Lead Boot may damage the Lead within the Lead Boot.

Be careful not to puncture or damage the DBS Lead or other components when administering the local anesthetic.

Do not bend locking joints.

Do not use polypropylene Sutures as they may damage the Suture Sleeve. Do not suture directly onto the Lead Extension or use a hemostat on the body of the Lead Extension. This may damage the insulation of the Lead Extension.

When planning the incisions necessary for connecting the Lead to the Lead Extension, ensure that there is enough length in the incision to expose the ends of the Lead and Lead Extension without excessive bending or kinking. Make an incision parallel to the path of the Lead and Lead Extension. Take care not to place an excessive bend in either Lead body adjacent to the Connector.

Take care not to bend or kink the DBS Lead or Lead Extension when inserting the proximal Lead array into the Lead Extension Connector. Take care not to over insert the Lead into the Lead Extension.

After connecting the DBS Lead to the Lead Extension, take care not to tug excessively on the Lead Extension.

Verify that the Lead Extension was properly inserted into the IPG Port by checking impedances before tightening the Setscrew. Tightening the Setscrew on a Contact can damage the Lead Extension.

The Hex Wrench is torque‑limiting so that the Setscrew cannot be overtightened. Use only the Hex Wrench provided, as other tools may overtighten the Setscrew and damage the Lead Extension.

Do not excessively bend the Lead bodies and Connectors while placing the DBS System under the skin and closing the incision.

Be careful not to damage the DBS Lead, IPG, or other implanted components when closing the incisions.

Loosen the Setscrew only as much as is necessary to remove the DBS Lead. Loosening the Setscrew too much will cause it to fall out.

Be careful not to damage any remaining implanted components when closing the incision.

 

Vercise™ Deep Brain Stimulation Systems Controller

Do not use the Vercise™ DBS Controller while the mobile device is charging.

You can only use one Controller App at a time as a patient remote. If you plan to temporarily pair a Stimulator, select “To temporarily control a patient’s stimulator” to avoid the patient’s Controller App being unable to communicate with the patient’s Stimulator.

 

StimSearch Programming

Use only Vercise PC, Vercise Gevia, or Vercise Genus DBS System components with Vercise Neural Navigator Software. Failure to do so may result in the inability to program the Stimulator.

The CP is not considered as equipment for the patient environment as defined by IEC 60601‑1. The CP and the person using the CP should not be in physical contact with the patient while programming.

 

ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

Explant of Non-MR Conditional Extensions and Stimulators for MRI: The fully implanted Lead‑Only MR Conditional system is comprised of a booted Leads system comprised of Leads, Lead Boots, and Burr Hole Covers listed in Table 2. The risk of explant to create a Leads‑Only MR Conditional configuration outlined in this manual should be evaluated by a healthcare professional.

Return of Symptoms: Patients may become anxious or their symptoms may return once stimulation is turned OFF. Ensure that the patient has been given the appropriate medical care to manage the return of symptoms before performing an MRI scan.

Read this manual in its entirety before performing an MRI scan on a patient implanted with any component listed in this manual.

MR Conditional scan may be safely performed when implanted with the components listed in this manual and when the patient is exposed to the MRI environment under specific conditions defined in this manual. Other configurations have not been evaluated.

If more than two Stimulators are implanted, the patient is not scan eligible.

When two Stimulators are implanted, a system containing DB‑3128‑55, DB‑3128‑55B, DB‑3128‑95, DB‑3128‑95B, DB‑3216‑55, or DB‑3216‑95 Lead Extension(s) is not scan eligible.

When two Stimulators are implanted, a system containing DB‑2203‑30, DB‑2203‑45, DB‑2204‑30, or DB‑2204‑45 Lead(s) is not scan eligible.

There should be no evidence of fractured or abandoned Leads or compromised Stimulator‑Lead integrity.

All Lead, Lead Extension, and Adapter M8 length combinations are scan eligible except those that include both a 95cm Medtronic Lead Extension (37085‑95 or 37086‑95) and a 55cm Adapter M8 (DB‑9218‑55).

Any system with an open Lead Extension Port is not scan eligible. Any system with an unused Medtronic Lead Extension Port is not scan eligible.

Abbott Extensions connected to a 55cm Adapter S8 (DB‑9208‑55) are MR Conditional only when the Stimulator is implanted in the abdomen. A 50cm Abbott Extension (6371) connected to a 15cm Adapter S8 (DB‑9208‑15) is MR Conditional only when the Stimulator is implanted near the clavicle (pectoral region).

Any system with an open Lead Extension Port is not scan eligible. Any system with an unused Abbott and/or Medtronic Lead Extension Port is not scan eligible.

A Vercise Gevia DBS Stimulator is not scan eligible when implanted in the abdomen.

If multiple Stimulators are implanted, the patient is not scan eligible.

Patients may become anxious, or their symptoms may return, once stimulation is turned OFF. Ensure that the patient has been given the appropriate medical care to manage the return of symptoms before performing an MRI scan.

Read this manual in its entirety before performing a MRI scan on a patient implanted with any component listed in this manual. Ensure that the implanted system meets the implant conditions listed in this manual before performing an MRI scan.

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

The following is a list of known risks with the use of deep brain stimulation. There may be risks that are unknown. Note that some of these symptoms may be resolved or reduced by current steering, changing stimulation parameters, or by changing the position of the Lead during surgery.

If any of these events occur, patients should inform their healthcare provider as soon as possible. Report any serious incident that occurs in relation to this device to Boston Scientific and to the relevant local regulatory authority for medical devices in your country.

Risks Associated With Surgical Procedure and Post‑Operative Period

• Allergic reaction to anesthesia or antibiotics including anaphylaxis
• Blood clot formation in the extremities (e.g., in the veins of the legs)
• Blood clot or air forming in or traveling through the blood stream, which can block blood flow to parts of the lungs or other tissue that could be life‑threatening
• Brain contusion (bruising)
• Brain or cerebral spinal fluid (CSF) fluid infection or inflammation
• CSF leaking outside the skull or collecting inside the skull abnormally
• Confusion or problems with attention, thinking, or memory (acute or chronic)
• Death
• Fibrosis (thickened skin and scarring) around the Lead Extension (including tightening, tethering, and bowstringing)
• Hemiparesis (muscular weakness or partial paralysis on one side of the body)
• Hemiballism (uncontrollable involuntary movements of a limb or limbs on one or both sides of the body)
• Intracranial hemorrhage (which can lead to stroke, paralysis, or death)
• Intraparenchymal cyst
• Infection
• Injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the brain
• Injury to the nerves in the armpit (brachial plexus) leading to pain or weakness of the arm or hand
• Neurosurgery/anesthesia risks, including unsuccessful implant and pneumonia
• Pain at the surgical site(s), headache or discomfort
• Seizures
• Speech or language difficulties
• Subcutaneous hemorrhage or seroma (blood or fluid collection under the skin, including the skin over the skull)
• Stroke resulting in temporary or permanent problems
• Swelling or bruising of the muscles or skin in the area of the Lead or of the IPG implant

Possible Side‑Effects of Stimulation

• Confusion or problems with attention, thinking, or memory
• Gait difficulty (trouble walking) and falls
• New onset or worsening depression, which may be temporary or permanent, and suicidal ideations, suicide attempts, and suicide
• Pain, headache or discomfort
• Pneumonia from difficulty with swallowing or from inhaling fluid
• Psychiatric disturbances such as anxiety, depression, lessened interest or emotion, hypersexuality, aggression, mania or hypomania, psychosis, emotional sensitivity, sleep problems, suicide, or suicidal thoughts or attempts
• Seizures
• Sensory changes
• Speech or language problems
• Swallowing difficulty
• Systemic effects such as rapid heart beat, changes in blood pressure, sweating, fever, dizziness, changes in kidney function, difficulty passing urine, sexual effects, nausea, difficulty having bowel movements, bloating
• Weakness, muscle spasms, shaking, restlessness, or problems with movement
• Undesirable sensations (e.g., tingling)
• Visual problems, eyelid or eye movement difficulties or other eye‑related symptoms
• Weight changes

Device‑Related Risks

• Allergic or immune system response to implanted materials
• Failure or malfunction of any part of the device, including but not limited to: Battery leakage, battery failure, Lead or Lead Extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and Lead insulation breaches, whether or not these problems require device removal and/or replacement
•  Implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening
• Implanted device components (Stimulator, Lead, or Lead Extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery
• Infection
• Interference from external electromagnetic sources
• Loss of adequate stimulation
• Pain, headache or discomfort
• Skin irritation or burns at the Stimulator site
• Stiffness in muscles or joints
• Worsening of disease symptoms, potentially caused by loss of stimulation, medication changes, surgery, or illness. In rare cases worsening can become a life‑threatening crisis associated with varied symptoms such as mental status changes, fever, and muscle rigidity
• Swelling, including fluid collecting around the device