Device Dossier

SenSight™ Directional Lead Kit - Brain electrical stimulation system, antitremor

Device Dossier for SenSight™ Directional Lead Kit - Brain electrical stimulation system, antitremor (Brain electrical stimulation system, antitremor,…

Intended purpose

The Medtronic Model B33005 / B33015 SenSight™ Directional Leads are part of a neurostimulation system for deep brain stimulation (DBS). The lead is an implanted device intended to conduct electrical stimulation to the intended target as part of the DBS system.

Functional description

The model B33005 / B33015 SenSight™ Directional Lead with 0.5 mm/1.5 mm axial spacing consists of eight insulated conductors bundled within polyurethane insulation. The conductors connect to the eight electrodes on the distal end of the lead. The leads with bilateral markers differentiate between hemispheres when 2 leads are implanted. The kit includes one Lead assembly, Stylet, Lead Cap, Torque Wrench and Product Literature.

TGA Public Summary