Serena Quad CRT-P MRI SureScan, W4TR05 - Biventricular pacemaker

Intended purpose

The Serena Quad CRT-P MRI SureScan Model W4TR05 system is indicated for heart failure patients who 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, who are indicated for ventricular pacing and have high degree AV block • Reduced EF and all of the following characteristics: – Have previously received a conventional pacemaker or an ICD – Have subsequently developed worsening heart failure despite optimal medical therapy – Have a high proportion of RV pacing Rate adaptive pacing is provided for patients who may benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

Functional description

The Medtronic Serena Quad CRT-P MRI SureScan Model W4TR05 dual chamber implantable pulse generator with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth wireless technology.