Device Dossier
Advisa DR MRI SureScan A3DR01 - Dual-chamber pacemaker, rate-responsive
Device Dossier for Advisa DR MRI SureScan A3DR01 - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor…
- GMDN category: Dual-chamber pacemaker, rate-responsive
Intended purpose
The Advisa 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 A3DR01 Advisa 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 and atrial tachyarrhythmia therapies. The MRI SureScan pacing feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.