Crome™ HF CRT-D MRI SureScan™ DTPC2D4 - Biventricular pacemaker/defibrillator

Intended purpose

The Medtronic Crome HF CRT-D MRI SureScan Model DTPC2D4 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 Model DTPC2D4 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates 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. This device features Bluetooth wireless technology. Lead Connector: IS-1/DF-4.