Vercise Genus Deep Brain Stimulation System

Indications, Safety and Warnings

Not intended as a substitute for the provided Patient Manual.

Intended Use / 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.

Safety Information 

Contraindications 

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 at the contact site 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 full 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 Vercise DBS 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 http://www.bostonscientific.com/manuals
 
Patient Incapability: Patients who are unable to properly operate the Remote Control and Charging System (when applicable) 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. 
 
 

Warnings 

 
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 within clinician-defined limits. The software prevents patient-controlled amplitude from exceeding the limit. 
 
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 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 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, Charging 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.bostonscientific.com/manuals 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, OR Cables, Remote Control, Charging System, Clinician Programmer, 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 health care 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. 
 
 

Precautions 

 
Physician training is required for usage of the Boston Scientific DBS System. The implanting physician should be experienced in the subspecialty of Stereotactic and Functional Neurosurgery. 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: 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 to avoid placing cell phones directly over the implanted Stimulator. If interference does occur, move the cell phone away from the implanted Stimulator or turn off the cell phone.  
 
Cleaning the Charging Belt or Charging Collar: Do not machine wash the Charging Belt or Charging Collar.  
 
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.  
 
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 OR 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 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 masseuse that they have an implanted device and show him/her where the Stimulator, DBS Lead Extensions, and DBS Leads are located. The patient should advise the masseuse 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 explanation 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 inch 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:  
  • Turn off stimulation at least five 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). 
 
Other Models of External Devices: Only the Remote Control, Charging System (as applicable), 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. 
 
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 two 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. 
 
Sterilization: Contents of the surgical kits are supplied sterile using an ethylene oxide 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. 
 
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: Store implanted components, such as the Stimulator, Leads, and Lead Extensions, between 0 °C to 45 °C (32 °F to 113 °F) in an area where they are not exposed to liquids or excessive moisture. Temperatures outside of the stated range can cause damage. If stored in conditions beyond the required storage temperature, do not use the components and return to Boston Scientific. 
 
The non-rechargeable Stimulator will enter storage mode if its temperature falls below 5 °C. When the Stimulator is in storage mode, it will not connect to a Remote Control or Clinician Programmer. To exit storage mode, increase the Stimulator temperature above 8 °C. 
 
Store external components like the Remote Control, External Trial Stimulator, ETS Adapter, OR Cable and Extension (DB-4100-A and SC-4100-A), and Charging System between -20 °C to 60 °C (-4 °F to 140 °F). Store the Push-Button OR 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.
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. 
 
 

Adverse Events 

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. 

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, 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 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 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.
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
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