Device Dossier

Sprint Quattro MRI SureScan Model 6946M - Lead, defibrillator, implantable

Device Dossier for Sprint Quattro MRI SureScan Model 6946M - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor…

Intended purpose

The Model 6946M 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 MRI SureScan Model 6946M lead is a steroid-eluting, quadripolar, tined tip, 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.

TGA Public Summary