Not intended as a substitute for the provided Vercise™ DBS Patient Manual.
The Vercise™ Deep Brain Stimulation (DBS) System is indicated for use in 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.
The Vercise™ 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 Vercise 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 Vercise 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 Vercise DBS System has not been established. It is possible that the energy generated by these therapies can be transferred to the Vercise DBS System, causing tissue damage that may result in severe injury or death.
Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise 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 Vercise DBS System.
Poor Surgical Candidates. The Vercise 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 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.
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 aspirin or prescribed anticoagulants, please notify your physician as these may increase your risk of intracranial hemorrhage.
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.
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:
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.
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.
Chemical burns may result if the Vercise Stimulator housing is ruptured or pierced and your tissue is exposed to battery chemicals.
Stimulators, such as the Vercise™ Stimulator, may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implantable cardioverter defibrillators, or medication delivery pumps. The effects of implanted stimulation devices on neurostimulators, such as the Vercise DBS System, are unknown.
Operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with caution after receiving the Vercise 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 Vercise™ 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 hurt an unborn baby.
Only the Remote Control and Charger that were provided with the Boston Scientific Vercise™ DBS System should be used with the Vercise DBS System. Other similar models of these devices will not function with the Vercise DBS System.
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.
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:
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:
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.
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.
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.
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:
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 for treatment of Parkinson's disease. 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.