Device Dossier

CoverEdge MRI 32 Contact Surgical Lead Kit - Electrode/lead, stimulator, implantable, neurological

Device Dossier for CoverEdge MRI 32 Contact Surgical Lead Kit - Electrode/lead, stimulator, implantable, neurological (Stimulator, electrical, analgesic,…

Intended purpose

The surgical paddle leads function as a component of the Precision Spectra™ Spinal Cord Stimulation systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. The 4x8 Surgical Lead is intended for use with the Precision Spectra System only.

Functional description

The distal end of the lead has 4 columns of 8 electrodes. On the proximal side, the lead has 4 tails. The end of each tail has 8 evenly spaced contacts. Each tail of the paddle lead is identified with marker bands. Each tail corresponds to the respective column of contacts on the paddle. Each tail can be inserted into an IPG to deliver electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord resulting in an inhibition of pain sensation.

TGA Public Summary