FDA Adverse Event
Other
Summary report: N
INSYNC MARQUIS
MDR report key: 596533
·
Received April 18, 2005
Report
- Report Number
- 596533
- Event Type
- Other
- Date Received
- April 18, 2005
- Date of Event
- December 19, 2003
- 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 ISCHEMIC CARDIOMYOPATHY, EJECTION FRACTION 25%, AND MULTIPLE ICD SHOCKS. THE PATIENT'S DEFIBRILLATOR HAS GONE OFF TWICE A MONTH AGO. THE PATIENT HAS HAD ONE EPISODE OF DOCUMENTED VENTRICULAR TACHYCARDIA REQUIRING ANTITACHYCARDIA PACING. THE DEVICE HAS BEEN ON ALERT FROM THE COMPANY AND GIVEN THE FACT THAT THIS PATIENT HAS HAD DOCUMENTED TACHYCARDIA REQUIRING TREATMENTS, AND IS HERE FOR GENERATOR CHANGE. (PER MD H&P)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC MARQUIS | ICD | NIK | MEDTRONIC, INC | 7278 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |