Device Dossier

Percept PC BrainSense B35200 - Brain electrical stimulation system, antitremor

Device Dossier for Percept PC BrainSense B35200 - Brain electrical stimulation system, antitremor (Brain electrical stimulation system, antitremor, Class…

Intended purpose

The implantable neurostimulator generates electrical pulses and delivers stimulation through 1 or 2 leads and extensions as part of a neurostimulation system for deep brain stimulation.

Functional description

Model B35200 Percept PC Neurostimulator with BrainSense with optional aDBS functionality for Parkinsons Disease is part of an active implantable device system for DBS and sensing. The neurostimulator generates electrical current that is conducted through DBS extensions and leads to the distal lead electrodes. The neurostimulator is a multiprogrammable device, and the stimulation settings are stored in programs. Programmable parameters include amplitude, pulse width, rate, and cycling.

TGA Public Summary