Device Dossier

SenSight™ Extension Kit Model B34000 - Brain electrical stimulation system, antitremor

Device Dossier for SenSight™ Extension Kit Model B34000 - Brain electrical stimulation system, antitremor (Brain electrical stimulation system,…

Intended purpose

The Medtronic Model B34000 SenSight™ Extension Kit is part of a neurostimulation system for Deep Brain Stimulation (DBS). The Extension is an implanted device intended to conduct electrical stimulation between the lead and the neurostimulator as part of the DBS system.

Functional description

The Extension lead has 8 contacts on both the distal and proximal ends, and uses a single setscrew connection. The Device is tunnelled from the subgaleal pocket where the distal end is connected to a DBS lead, to the pectoral pocket where the proximal end is connected to the INS. Models identified with the letter M include 2 bilateral markers and a radiopaque marker. The package contains 1 Extension (contains a preinserted setscrew), 1 setscrew (extra), 1 Torque wrench and product literature.

TGA Public Summary