Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D1 - Biventricular pacemaker/defibrillator

Intended purpose

The Medtronic Cobalt XT HF CRT-D MRI SureScan Model DTPA2D1 implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions: • Ventricular dyssynchrony with prolonged QRS • Reduced ejection fraction (EF), regardless of New York Heart Association (NYHA) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (AV) block • Reduced EF with all the following characteristics: – The patient received a conventional pacemaker or an implantable cardioverter defibrillator (ICD). – The patient subsequently developed worsening heart failure despite optimal medical therapy. – The patient has a high proportion of right ventricular (RV) pacing

Functional description

The devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (CRT-D). These multiprogrammable cardiac devices monitor and regulate the patient’s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. The devices feature Bluetooth wireless technology. Lead Connector: IS-1/DF-1