Device Dossier

Aurora EV-ICD MRI SureScan DVEA3E4 - Defibrillator, implantable, automatic

Device Dossier for Aurora EV-ICD MRI SureScan DVEA3E4 - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor…

Intended purpose

The Medtronic Aurora EV-ICD MRI SureScan Model DVEA3E4 is a single chamber, extravascular implantable cardioverter defibrillator (ICD). It is a magnetic resonance (MR) conditional, multi-programmable cardiac device that monitors and regulates the patient’s heart rate. It provides ventricular tachyarrhythmia detection and therapy, post-shock pacing, and prolonged pause detection and therapy (Pause Prevention pacing). The device also provides diagnostic and monitoring features to assist with system evaluation and patient care.

Functional description

The Medtronic Aurora EV-ICD MRI SureScan Model DVEA3E4 single chamber, implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate. It provides ventricular tachyarrhythmia detection and therapy, post-shock pacing, and prolonged pause detection and therapy (Pause Prevention pacing). The device also provides diagnostic and monitoring features to assist with system evaluation and patient care.

TGA Public Summary