Indications for Use: The Boston Scientific Deep Brain Stimulation Systems are 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.
-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.
Contraindications, warnings, precautions, side effects: The Deep Brain Stimulation Systems or any of its components, is contraindicated for: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) as the safety of these therapies in patients implanted with the Vercise™ DBS System has not been established, patients who are unable to operate the system, patients who are poor surgical candidates or who experience unsuccessful test stimulation. Patients implanted with Boston Scientific Deep Brain Stimulation Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Patients implanted with Vercise Gevia™ or Vercise Genus™ or Vercise DBS Lead-only system (before Stimulator is implanted) with ImageReady MRI Technology are Full Body MR Conditional only when exposed to the MRI environment under the specific conditions defined in ImageReady MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems. 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. Monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control and manage appropriately. Refer to the Instructions for Use provided with the Vercise DBS System or BostonScientific.com for potential adverse effects, warnings, and precautions prior to using this product.
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 the Vercise DBS System 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 detection systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. The system should not be charged while sleeping. If you notice new onset or worsening depression, changes in mood or behavior or impulse control, or have thoughts of suicide contact your physician or emergency services immediately. Chemical burns may result if the Vercise 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 System. 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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