Recall Z-0812-04 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc. Cardiac Rhythm Managment
Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271
| Date | Jul 20, 2004 (initiated Apr 2, 2004) |
| Status | Terminated |
| Reason | Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices. |
| Root cause | Other |
| Action | A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification. |
| Quantity | 250 units (34 units in the United States) |
| Distribution | Nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.