Device Dossier

Sprint Quattro Secure MRI SureScan Model 6947 - Lead, defibrillator, implantable

Device Dossier for Sprint Quattro Secure MRI SureScan Model 6947 - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor…

Intended purpose

The Model 6947 lead is intended for use in the right ventricle for sensing, pacing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening tachyarrhythmias.

Functional description

The Medtronic Sprint Quattro Secure MRI SureScan 6947 lead is a steroid-eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. This lead is designed for pacing, sensing, cardioversion, and defibrillation therapies. The lead has been tested for use in the Magnetic Resonance Imaging (MRI) environment.

TGA Public Summary