Device Dossier

Infinion 16 Contact Lead Kit - Electrode/lead, stimulator, implantable, neurological

Device Dossier for Infinion 16 Contact Lead Kit - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead, Class…

Intended purpose

The Infinion 16 contact Lead kit is used with the Precision SCS system as an aid in the management of chronic intractable pain by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. This is intended to be used for the permanent implant phase.

Functional description

The lead has 16 contacts located near the distal end. Each contact is 3mm in length and is spaced 1mm for the adjacent contact. The Infinion 16 contact lead is inserted into a splitter 2x8 (supplied separately) which then connects to a Precision IPG’s 8 contact ports or 8 contact OR cables. The kit also contains stylets, suture sleeves, insertion needle.

TGA Public Summary