Indications for Use: The Vercise™ Deep Brain Stimulation (DBS) Systems are indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as adjunctive therapies in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson's disease (PD) that are not adequately controlled with medication.
Contraindications: The Vercise DBS Systems are not recommended for patients who will be exposed to the following procedures: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS). The safety of these therapies in patients implanted with Vercise DBS Systems has not been established. Patients implanted with Vercise DBS Systems should not have Magnetic Resonance Imaging (MRI). Vercise DBS Systems is not recommended for patients who are unable to operate the system or are poor surgical candidates or who experience unsuccessful test stimulation.
Warnings: Unauthorized modification to the medical devices is prohibited. You should not be exposed to high stimulation levels. High level of stimulation may damage brain tissue. Patients implanted with Vercise DBS Systems may be at risk for intracranial hemorrhages (bleeding in the brain) during DBS lead placement. Strong electromagnetic fields, such as power generators, security screeners or theft detections systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. The system should not be charged while sleeping. If you notice changes in mood or behavior or have thoughts of suicide contact your physician immediately. Chemical burns may result if the Stimulator housing is ruptured or pierced. The Deep Brain Stimulation System may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implanted cardioverter defibrillators, or medication delivery pumps. Patients should operate motorized vehicles or potentially dangerous machinery with caution. It is unknown if the device may hurt an unborn baby. Your doctor may be able to provide additional information on the Boston Scientific Vercise DBS Systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 833-DBS-INFO or 833-327-4636.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
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