Device Dossier

Ensura DR MRI SureScan EN1DR01 - Dual-chamber pacemaker, rate-responsive

Device Dossier for Ensura DR MRI SureScan EN1DR01 - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor…

Intended purpose

The Ensura DR MRI SureScan system is indicated to restore physiologic heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The device is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity.

Functional description

The Medtronic Model EN1DR01 Ensura DR MRI SureScan dual chamber implantable pacemaker is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing.

TGA Public Summary