Recall Z-1661-2014 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medt
| Date | May 24, 2014 (initiated Apr 29, 2014) |
| Status | Terminated |
| Reason | Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time. |
| Root cause | Device Design |
| Action | Consignees were sent a Medtronic "Urgent Medical Device Correction" letter dated April 2014. The letter was addressed to Risk Manger, Health Care Professional. The letter included the Issue Description, Root Cause, Potentially Affected 5348 EPGs within the Serial Number Ranges, Malfunction Indications, and Recommended Actions. For questions related to EPG service policy or purchasing a replacement EPG, customers should contact your Medtronic representative. For technical questions, please call Instruments Technical Service at (1-800)638-1991. Medtronic asks that customers complete and sign |
| Quantity | 16,337 (8,989 US; 7,348 OUS) |
| Distribution | Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Cro |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.