Device Dossier
Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive
Device Dossier for Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor Abbott…
- GMDN category: Dual-chamber pacemaker, rate-responsive
Intended purpose
The Endurity MRI PM2172 is intended to be implanted when a patient has one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. It monitors and regulates a patient's heart rate by providing bradycardia therapy and dual-chamber pacing. The implantation of Endurity MRI PM2172 is also intended for patients exhibiting: sick sinus syndrome, chronic, symptomatic second-degree and third-degree AV block, recurrent Adam-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.
Functional description
The Endurity PM2172 is a MRI conditional, dual-chamber pulse generator. This device can be programmed with the Merlin Patient Care System and has device header with IS-1 connector for connection of unipolar or bipolar IS-1 leads. The devices are 1.5 and 3T MR conditional. For MR conditional Device/Lead Combinations refer to manufacturer’s MR conditional Systems Manual.