Crome™ VR MRI SureScan™ DVPC3D4 - Defibrillator, implantable, automatic

Intended purpose

The Medtronic Crome VR MRI SureScan Model DVPC3D4 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 Model DVPC3D4 single chamber, implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber, rate-responsive bradycardia pacing and ventricular tachyarrhythmia therapies. This device features Bluetooth wireless technology.