Device Dossier

Neutrino NxT HF CRT-D Model CDHFA600D - Biventricular pacemaker/defibrillator

Device Dossier for Neutrino NxT HF CRT-D Model CDHFA600D - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III,…

Intended purpose

For use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. In addition, these devices 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 right atrium. CRT‑D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles.

Functional description

The device is a cardiac resynchronization therapy defibrillator (CRT-D) monitors and regulates a patient's heart rate and provides treatment of ventricular arrhythmias. As a CRT-D device, it also senses cardiac activity and provides pacing to resynchronize the right and left ventricles. The device has a device header which allows for connection of bipolar leads in an IS1 LV port. The device is MR conditional.

TGA Public Summary