Device Dossier
Vercise DBS Clinician Programmer - Computer, laptop
Device Dossier for Vercise DBS Clinician Programmer - Computer, laptop (Computer, laptop, Class III, sponsor Boston Scientific). ARTG record, intended…
- GMDN category: Computer, laptop
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 Clinician Programmer (CP) is a computer installed with programming software. It is used to set and adjust stimulation parameters for the Vercise PC System by communicating with the Stimulator wirelessly via a Programming Wand.