FDA Adverse Event
Other
Summary report: N
MEDTRONIC INSYNC MARQUIS
MDR report key: 597122
·
Received April 18, 2005
Report
- Report Number
- 597122
- Event Type
- Other
- Date Received
- April 18, 2005
- Date of Event
- September 21, 2004
- Report Date
- April 18, 2005
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NIK
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
MEDTRONIC RECALL OF ICD GENERATOR DEVICE SECONDARY TO POSSIBLE BATTERY MALFUNCTION. A PATIENT WITH A HISTORY OF VENTRICULAR TACHYCARDIA, CORONARY ARTERY DISEASE, SKIN CANCER AND GASTROESOPHAGEAL REFLUX DISEASE. ON COUMADIN FOR VENOUS THROMBOSIS STATUS POST INITIAL ICD PLACEMENT. THE PATIENT WAS NOTIFIED BY THE PHYSICIAN OF RECALL ALERT BY MEDTRONIC (EVIDENCE IN A SMALL NUMBER OF DEVICES THAT THE BATTERY MAY RAPIDLY DEPLETE WITHOUT WARNING). THE PATIENT WAS WORRIED AND ANXIOUS AND REQUESTED GENERATOR BE REPLACED RATHER THAN HAVE TO CONTINUE TO WORRY ABOUT THE DEVICE FUNCTIONING APPROPRIATELY. PER MEDICAL DOCTOR'S HISTORY AND PHYSICAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC INSYNC MARQUIS | ICD | NIK | MEDTRONIC, INC. | 7278 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |