Device Dossier
Vercise DBS Remote Control 2 Kit - Brain electrical stimulation system, antitremor
Device Dossier for Vercise DBS Remote Control 2 Kit - Brain electrical stimulation system, antitremor (Brain electrical stimulation system, antitremor,…
- GMDN category: Brain electrical stimulation system, antitremor
Intended purpose
The Vercise™ PC System is an implantable Deep Brain Stimulator (DBS) system indicated for use in the following: • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa-responsive Parkinson’s disease which is not adequately controlled with medication. • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for intractable primary and secondary dystonia, for persons 7 years of age and older. • Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.
Functional description
The remote control is a hand-held device that communicates with the stimulator through a radio frequency (RF) telemetry link.