FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 2243010
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06199
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- March 25, 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
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. LATE DUE TO DELAY IN RECEIVING PAPERWORK. THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY AFTER PERFORMING LONGEVITY CALCULATIONS. DEVICE WAS TESTED ON THE BENCH AND NO SOURCES OF HIGH CURRENT WERE FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED EARLY EOL. IT WAS EXPLANTED AND REPLACED.
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 | 62 YR | Required Intervention |