Device Dossier

Proclaim DRG IPG, Model 3664 - Analgesic spinal cord electrical stimulation system pulse generator implantable

Device Dossier for Proclaim DRG IPG, Model 3664 - Analgesic spinal cord electrical stimulation system pulse generator implantable (Analgesic spinal cord…

Intended purpose

The neurostimulation 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.

Functional description

The IPG is designed to be connected to one or more leads or extensions with up to 16 electrodes total, is powered by a hermetically sealed battery within a titanium case, uses microelectronic circuitry to generate constant-current electrical stimulation & can deliver stimulation with a single program or with multiple programs. Each programme can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers & controllers.

TGA Public Summary