FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1223132
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03741
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION NINE MONTHS POST IMPLANT. THE END OF LIFE (EOL) FLAG WAS TRIGGERED IN 2008 ALTHOUGH THE BATTERY VOLTAGE WAS WITHIN NORMAL RANGE IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |