Device Dossier

Quadra Assura MP CRT-D Model CD3371-40C - Biventricular pacemaker/defibrillator

Device Dossier for Quadra Assura MP CRT-D Model CD3371-40C - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III,…

Intended purpose

Intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing, and ventricular cardioversion/defibrillation. In addition, the device can detect and treat chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle, and various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or the right atrium. Being a CRT-D device, the device sense cardiac activity and provide pacing to resynchronise the right and left ventricles.

Functional description

The Quadra Assura MP CRT-D Model CD3371-40C is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient's heart rate. The device also provides pacing to resynchronise the right and left ventricles.

TGA Public Summary