Vercise™ PC and Vercise Gevia™ Deep Brain Stimulator Systems
Indications, Safety and Warnings
Intended Use / Indications for Use
When the Device Should Not be Used (Contraindications)
The DBS System should not be used in cases where patients have the following conditions or will be exposed to the following procedures:
- Diathermy. You should not have any form of diathermy either as treatment for a medical condition or as part of a surgical procedure. The energy generated by diathermy can be transferred to the DBS System, causing tissue damage in the brain, which can result in severe injury or death. The use of shortwave, microwave, and/or therapeutic ultrasound diathermy with the DBS System implanted may result in severe injury or death.
- Electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). The safety of these therapies in patients implanted with the DBS System has not been established. It is possible that the energy generated by these therapies can be transferred to the DBS System, causing tissue damage that may result in severe injury or death.
- Magnetic Resonance Imaging (MRI). Patients implanted with the DBS System should not have an MRI. Patient exposure to MRI can cause (1) dislodgement of implanted components, (2) heating of the contacts or other system components, causing permanent tissue damage, including damage to brain tissue, (3) damage to the device electronics, (4) changes in current flow, causing unpredictable levels of stimulation, (5) distortion of the MRI image, and/ or (6) personal injury or death.
- Patient Incapability. If you are unable to properly operate the Remote Control and Charging System, then you should not be implanted with the DBS System.
- Poor Surgical Candidates. The DBS System is not recommended for patients who are poor surgical candidates. Please consult with your doctor to determine your surgical risk.
- Unsuccessful Test Stimulation. The Vercise DBS System should not be used in patients who experience unsuccessful test stimulation.
- Unauthorized Modification. 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.
- Intracranial Hemorrhage. Placement of the DBS Leads in the brain may increase the risk of intracranial hemorrhages (i.e., bleeding in the brain). If you are more prone to hemorrhage, have trouble forming blood clots (i.e., coagulothapy), or take medication to make your blood thinner, such as baby aspirin or prescribed anticoagulants, please notify your physician as these may increase your risk of intracranial hemorrhage.
- High Stimulation Levels. High levels of stimulation may damage brain tissue. Your physician will set the maximum and minimum stimulation levels allowed by the Remote Control to ensure that stimulation levels remain safe.
- Electromagnetic Interference
Strong electromagnetic fields can potentially turn the Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the Remote Control communication. You should avoid or exercise care around:
- Theft detectors, such as those used at department stores, libraries, and other public establishments. If you must proceed through the detector, you should proceed with caution, ensuring to move through the center of the detector as quickly as possible.
- Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand-held scanners. It is recommended that you request assistance to bypass the screener. If you must proceed through the security screener, proceed with caution, ensuring to move quickly through the security screener and staying as far from the screener as allowable.
- Power lines or power generators.
- Electric steel furnaces and arc welders.
- Large magnetized stereo speakers.
- Strong magnets.
- Automobiles or other motorized vehicles using a LoJack system or other anti-theft system that can broadcast a radio frequency (RF) signal. The high energy fields produced by these systems may interfere with the operation of the Remote Control and its ability to control stimulation.
- 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.
Note: When in close proximity, 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
The Charger may become warm while charging the Stimulator. The Charger should be handled with care. Failure to use either the Charging Collar or an Adhesive Patch while charging, as directed, may result in a burn. You should not charge while sleeping. This may result in a burn. If you experience pain or discomfort, stop charging and contact your physician.
If you notice unusual changes in mood or behavior or have thoughts of suicide, contact your physician immediately.
- Stimulator Damage
Chemical burns may result if the Vercise Stimulator housing is ruptured or pierced and your tissue is exposed to battery chemicals.
- Other Implanted Stimulation Devices Stimulators. Concurrent use of the Stimulator and other implantable stimulation devices such as pacemakers, cardioverter defibrillators, or medication delivery pumps may result in interference with the operations of the devices. If you require concomitant implantable stimulation devices, careful programming of each system is necessary. If there is a concern or a problem is encountered, please contact your physician.
- Automobiles and Equipment
Operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with caution after receiving the DBS System. Avoid performing activities that would be dangerous if treated symptoms were to return. Actions that cause stimulation changes to occur should be avoided. Impaired driving performance and an increased accident risk have been previously reported for patients with Parkinson’s disease.
- If your DBS System ceases treatment for any reason while operating a car, any other motorized vehicle, or potentially dangerous machinery/equipment, you are at an increased risk of causing injury or death to yourself and others.
It is unknown whether this device may cause complications and/or hurt an unborn baby.
- Other Models of External Devices
Only the Remote Control and Charger that were provided with the Boston Scientific Vercise Gevia DBS System should be used with the Vercise PC DBS System. Other similar models of these devices will not function with the Vercise PC DBS System.
- Stimulator Orientation
Never attempt to change the orientation of or turn over the Stimulator. Avoid touching the Stimulator site or incisions. If the Stimulator flips over in your body, then it cannot be charged. If stimulation cannot be turned on after charging, contact your physician to arrange an evaluation of the system. If you notice a change in appearance of the skin at the Stimulator location, such as the skin becoming thin over time,contact your physician.
- Device Failure
Implants can fail at any time due to random component failure, loss of battery functionality, DBS Lead breakage, or DBS Lead migration. Suddenly stopping brain stimulation can cause serious reactions to develop. If the Stimulator stops working even after complete charging, turn off stimulation and contact your physician immediately so that the system can be evaluated and appropriate medical care given to manage the return of symptoms.
Following your surgery, the medical staff will ensure that you will receive standard medical care:
- A CT Scan may be taken to record the position of the DBS Leads and Stimulator.
- You and a family member will be educated on the system operations, including instructions on how to turn stimulation on and off, how to charge the Stimulator’s battery, and realistic expectations of stimulation in the treatment of your disease.
- Antibiotics may be prescribed to prevent infection.
- Post-operative pain concerns will be addressed by your physician prior to discharge from the hospital.
- A responsible adult companion who is able to fully understand the post-operative care instructions will be required to drive you home after the surgery.
During the period following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incision:
- You should restrict head movements, as instructed by your physician, including extension or flexion of the neck and rotation of the head, until healing is complete.
- Do not attempt to move heavy objects.
- Do not shower until cleared by your physician. Surgical sutures and staples will need to be removed by your physician in a follow-up visit after surgery.
- Follow your physician’s instructions regarding how to care for the dressing covering the area where the Stimulator has been implanted.
Initiating your stimulation therapy may be delayed up to two months until swelling (edema) is resolved. The timing will depend on your physician’s judgment. If swelling is still present at the Stimulator site (typically in the chest area) once stimulation therapy has begun, swelling may lead to longer charging times or the inability to charge the Stimulator. Post-surgical swelling is expected to subside. If you experience continued swelling, contact your physician.Temporarily, there may be some pain in the area of the Stimulator until healing is complete. If discomfort continues beyond two weeks, contact your physician. If you notice excessive redness or drainage around the wound areas, contact your physician. In rare cases, adverse tissue reaction to implanted materials can occur.
While interference caused by cell phones is not anticipated, the full effects of interaction with cell phones are unknown at this time. If there is a concern or a problem is encountered, please contact your physician.
You should avoid receiving massage therapy near the implanted system components. If you do receive massage therapy, inform the masseuse that you have an implanted device and show him/her where the Stimulator, DBS Extension, and DBS Leads are located. Have the masseuse avoid these areas and proceed with caution.
The following medical therapies or procedures may turn stimulation off, cause permanent damage to the Stimulator, or may cause you injury, particularly if used in close proximity to the device. 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 as a result of damage to the device or severe injury.
- Electrocautery—The use of a heated electric probe to stop bleeding during surgery
- External Defibrillation—The use of electrically charged paddles to restart the heart in an emergency
- Lithotripsy—High-output sound or shock waves often used to treat gall stones and kidney stones
- Radiation Therapy—Ionizing energy commonly used to treat cancer. 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.
Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is turned off.
Before having these procedures, medical therapies, or diagnostics, have your healthcare professional call the Boston Scientific Technical Support department for proper instructions.
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 Charging System should not be disposed of in fire. These components contain batteries, which may explode causing injury when exposed to fire. Used batteries should be disposed of in accordance with local laws and regulations.
The operating temperature of the Remote Control is 10–40 °C (50–104 °F). For proper operation, do not use the Charging System if the ambient temperature is above 35 °C (95 °F).
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.
- For proper operation, do not use the Charger if the ambient temperature is above 35° C (95° F).
- If the Remote Control or the Charging System is to be stored for a period of time, be careful that the storage temperature does not exceed -20–60° C (-4–140° F).
- Handle the system components and accessories with care. Do not drop them or submerge them in water. Accessories, including the Remote Control, Charger, and charging components must be kept dry and not be exposed to moisture.
- 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, Charger, and charging components away from pets, pests, and children to avoid damage to the devices.
Remote Control and Charging System Cleaning
- The external components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.
- Remove the Charger and Counterweight from the Charging Collar before washing the Charging Collar.
- Wash the Charging Collar with mild soap and warm water.
- Do not machine wash the Charging Collar.
- Let the Charging Collar air dry.
- Do not use the Charging Collar when it is damp or wet.
- Do not clean the Charger, Base Station, or Power Supply while they are directly or indirectly connected to a power outlet.
As an operator of the external devices, you should perform only the following service and maintenance tasks on the external devices:
- Charging the battery
Ensure that the devices are not in use while performing service and maintenance tasks.
The following is a list of known risks with the use of deep brain stimulation. It is possible there are 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 DBS Lead during surgery. If any of these events occur, you should contact your physician as soon as possible to inform them.
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) infection or inflammation
- Cerebral spinal fluid leaking outside the skull or collecting inside the skull abnormally.
- Confusion or problems with attention, thinking, or memory (acute or chronic)
- 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
- 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
- Speech or language difficulties
- Subcutaneous hemorrhage or seroma (blood or fluid colletion 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
- Confusion or problems with attention, thinking, or memory
- Gait difficulty (trouble walking) and falls
- 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, pyschosis, emotional sensitivity, sleep problems, suicide, or suicidal thoughts or attempts
- 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
- 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
- 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