Device Dossier

Surgical Lead Kit – Model LEAD30yyxx(B) - Stimulator, electrical, analgesic, spinal cord

Device Dossier for Surgical Lead Kit – Model LEAD30yyxx(B) - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic, spinal…

Intended purpose

The permanent stimulation Surgical Leads are a component of the Nevro Senza Spinal Cord Stimulation (SCS) system 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, Leg pain and delivers constant high frequency therapy (HF10) stimulation through 1 or multiple leads.

Functional description

The Surgical Leads carry electrical stimulation to the nerve structures. The proximal end has two legs each with 8 contacts with a stiffer proximal end to aid insertion into the connector of a lead extension or implantable pulse generator (IPG). The distal end of the lead is moulded out of silicone and has 16 distal electrodes arranged in two columns. The kit includes the surgical lead, stylet preloaded in the lead and silicone lead anchors.

TGA Public Summary