FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR, DF4 CONNECTOR
MDR report key: 3210418
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03373
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 26, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION. AN INTERNAL BATTERY ANOMALY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED A RAPID BATTERY DEPLETION IN A SHORT PERIOD OF TIME. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310659 | CURRENT PLUS DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |