Device Dossier
Ensura SR MRI SureScan Model EN1SR01 - Single-chamber pacemaker, rate-responsive
Device Dossier for Ensura SR MRI SureScan Model EN1SR01 - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, Class…
- GMDN category: Single-chamber pacemaker, rate-responsive
Intended purpose
The Ensura SR 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 Ensura SR MRI SureScan Model EN1SR01 single chamber implantable pacemaker is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber rate-responsive bradycardia pacing therapies.