Proclaim 5 IPG, Model 3661 - Analgesic spinal cord electrical stimulation system pulse generator implantable

Intended purpose

The Implantable Pulse Generator, a component within a Spinal Cord Stimulation system, is designed to deliver low intensity electrical impulses to nerve structures. The neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.

Functional description

An electronic device designed to connect to one or more extensions/leads with up to 16 electrodes. Powered by a hermetically sealed battery in a titanium case, uses microelectronic circuitry to generate constant current electrical stimulation. Delivers stimulation with a single or multiple programs. Communicates wirelessly with system programmers & controllers. Has a compatible header that enables it to connect to non SJM leads or extensions that meet compatibility guidelines.