Device Dossier

SelectSecure MRI SureScan 3830 - Lead, pacemaker, implantable, endocardial

Device Dossier for SelectSecure MRI SureScan 3830 - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III,…

Intended purpose

The Model 3830 lead is intended for pacing and sensing in the right atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to right ventricular pacing in a single or dual chamber pacing system.

Functional description

The device is a steroid eluting, bipolar, transvenous, nonretractable screw-in, atrial/ventricular, catheter delivered lead. It has a nonretractable helical electrode for active fixation in the endocardium by rotating the lead body in a clockwise direction. The lead also has a second, larger ring electrode proximal to the tip electrode and an IS-1 Bipolar (BI) connector. Upon exposure to body fluids, the steroid elutes from the lead tip.

TGA Public Summary