Recall Z-0601-05 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician.
| Date | Mar 11, 2005 (initiated Feb 9, 2005) |
| Status | Terminated |
| Reason | Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function. |
| Root cause | Other |
| Action | Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care. |
| Quantity | 2,542 total, (2,217 in US & 325 OUS) |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.