Device Dossier

Cobalt™ XT VR MRI SureScan™ DVPA2D1 - Defibrillator, implantable, automatic

Device Dossier for Cobalt™ XT VR MRI SureScan™ DVPA2D1 - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor…

Intended purpose

The Medtronic Cobalt XT VR MRI SureScan Model DVPA2D1 device is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. Medical conditions that may indicate a patient for an ICD for primary or secondary prevention of sudden cardiac death due to life-threatening ventricular tachyarrhythmias include: • Previous ventricular tachyarrhythmias • Acute Coronary Disease • Left Ventricular Dysfunction • Cardiomyopathy • Inherited Primary Arrhythmia Syndromes • Congenital Heart Disease • Inflammatory, Rheumatic and Valvular Heart Disease

Functional description

The devices are single chamber, implantable cardioverter defibrillators (ICD). They are multiprogrammable cardiac devices that monitor and regulate the patient’s heart rate by providing single chamber, rate-responsive bradycardia pacing and ventricular tachyarrhythmia therapies. This device features Bluetooth wireless technology. Lead Connector Type: IS-1/DF-1

TGA Public Summary