FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 2242855
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06195
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 22, 2011
- 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
- RI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE WAS FOUND TO BE BELOW THE EXPECTED LIMITS. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING BENCH, AUTOMATED ELECTRICAL, TEMPERATURE, AND HUMIDITY TESTING. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS, AND NO ANOMALY WAS DETECTED THAT WOULD CAUSE THE BATTERY TO DEPLETE. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT CONCLUSIVELY BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.
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 | 52 YR | Required Intervention |