Device Dossier

Liberta RC™ DBS IPG Model 62400 - Brain electrical stimulation system, antitremor

Device Dossier for Liberta RC™ DBS IPG Model 62400 - Brain electrical stimulation system, antitremor (Brain electrical stimulation system, antitremor,…

Intended purpose

The Liberta RC™ Deep Brain Stimulation (DBS) System is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system and is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications. 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.

Functional description

The Liberta RC DBS IPG is a hermetically sealed cannister with an epoxy header containing two 8 channel lead ports; it is powered by a rechargeable lithium-ion battery and provides stimulation to targeted nuclei within the brain via compatible leads and extensions.

TGA Public Summary