Device Dossier

Infinity 7 IPG, Model 6662 - Brain electrical stimulation system, antitremor

Device Dossier for Infinity 7 IPG, Model 6662 - Brain electrical stimulation system, antitremor (Brain electrical stimulation system, antitremor, Class…

Intended purpose

The neurostimulation system is indicated for unilateral or bilateral stimulation of the thalamus, internal globus pallidus or subthalamic nucleus in patients who are at least 18 years old with levodopa-responsive Parkinson’s disease; unilateral or bilateral stimulation of the ventral intermediate nucleus of the thalamus for the management of tremor for patients who are at least 18 years old; unilateral or bilateral stimulation of the internal globus pallidus of the subthalamic nucleus for the management of intractable, chronic dystonia, including primary and secondary dystonia for patients who are at least 7 years old. The device is MR conditional.

Functional description

The IPG is designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers.

TGA Public Summary