Visia AF MRI S VR SureScan Model DVFC3D1 - Defibrillator, implantable, automatic

Intended purpose

The Visia AF MRI S VR SureScan Model DVFC3D1 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 Medtronic Model DVFC3D1 Visia AF MRI S VR SureScan 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