Recall Z-0665-2009 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.
| Date | Jan 28, 2009 (initiated Jul 25, 2008) |
| Status | Terminated |
| Reason | Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm |
| Root cause | Process design |
| Action | A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090. |
| Quantity | 419 |
| Distribution | No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.