Device Dossier

Octrode Lead Kit 3186 - Implantable lumbar neuromuscular electrical stimulation system lead

Device Dossier for Octrode Lead Kit 3186 - Implantable lumbar neuromuscular electrical stimulation system lead (Implantable lumbar neuromuscular…

Intended purpose

The percutaneous leads are intended to be used with Abbott Medical neurostimulation systems by connecting to a compatible pulse generator, either directly or with a compatible lead extension. Indications for Use: This 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

SCS uses low-intensity electrical impulses to stimulate nerve fibres within the spinal cord, often inhibiting chronic pain messages from reaching the brain. The leads are designed for introduction into the epidural space. The lead assembly consists of 8 cylindrical electrodes spaced at precise intervals. Kit contains a guide wire, tunnelling tool, lead anchor, epidural needle, lead introducer and stylet.

TGA Public Summary