Device Dossier

Surpass-C Surgical Lead Kit - Model LEAD200X-YYB - Stimulator, electrical, analgesic, spinal cord

Device Dossier for Surpass-C Surgical Lead Kit - Model LEAD200X-YYB - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic,…

Intended purpose

The Surpass-C Surgical Lead Kit is a component of the Senza neuromodulation system indicated to 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, intractable low back pain, and leg pain.

Functional description

The surgical lead is used with a Nevro IPG or trial stimulator for delivering stimulation. The distal end is silicon, has 8-14 platinum/iridium alloy distal electrodes, arranged in 2 columns. The proximal end has two Pellethane isodiametric legs each with 8 contacts that attach to a Nevro IPG, lead extension or OR cable. Each proximal leg has 4-7 low impedance cables that conduct signals from a proximal contact to a distal electrode. Kit contents: Surpass-C Surgical Lead and silicone anchors.

TGA Public Summary