BRIEF SUMMARY:

As with any surgery or therapy, deep brain stimulation has risks and complications. The risk of serious side effects from DBS is low, particularly with an experienced surgical team. Most side effects of DBS surgery are temporary and correct themselves over time. Some people may experience lasting, stroke-like symptoms, such as weakness, numbness, problems with vision or slurred speech. In the event that the side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed.

Risks of brain surgery include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal.

INDICATIONS FOR USE:

Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications, and unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Contraindications: Patients who are unable to operate the system or for whom test stimulation is unsuccessful. Diathermy, electroshock therapy, and transcranial magnetic stimulation (TMS) are contraindicated for patients with a deep brain stimulation system. Warnings/Precautions: Return of symptoms due to abrupt cessation of stimulation (rebound effect), excessive or low frequency stimulation, risk of depression and suicide, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), electromagnetic interference (EMI), proximity to electrosurgery devices and high-output ultrasonics and lithotripsy, ultrasonic scanning equipment, external defibrillators, and therapeutic radiation, therapeutic magnets, radiofrequency sources, explosive or flammable gases, theft detectors and metal screening devices, activities requiring excessive twisting or stretching, operation of machinery and equipment, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. Adverse Effects: Loss of therapeutic benefit or decreased therapeutic response, painful stimulation, persistent pain around the implanted parts (e.g. along the extension path in the neck), worsening of motor impairment, paresis, dystonia, sensory disturbance or impairment, speech or language impairment, and cognitive impairment. Surgical risks include intracranial hemorrhage, stroke, paralysis, and death. Other complications may include seizures and infection. Clinician’s manual must be reviewed for detailed disclosure.

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SJM-INF-0817-0127 | Item approved for global use.