Recall Z-1356-2015 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purp
| Date | Mar 31, 2015 (initiated Mar 17, 2015) |
| Status | Terminated |
| Reason | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy. |
| Root cause | Device Design |
| Action | Medtronic sent an "Urgent Medical Device Correction" letter dated March 2015 to affected customers. The letter was addressed to Risk Manager or Health Care Professional. The letter described the Issue and Customer Actions to be taken. The letter requested customers to complete and return the Customer Confirmation Certificate. For questions contact your Medtronic representative, for technical questions call Instrument Technical Service at 800-638-1991. |
| Quantity | 6040 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR, VI and the countries of:Australia, Austria, Bahamas, Belgium, Bolivia , |
| FDA record | Open on fda.gov |