Crome™ DR MRI SureScan™ DDPC3D1 - Defibrillator, implantable, automatic, dual-chamber

Intended purpose

The Medtronic Crome DR MRI SureScan Model DDPC3D1 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 dual chamber, implantable cardioverter defibrillators (ICD). They are multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. The devices feature Bluetooth wireless technology. Lead connector type: IS-1/DF-1