FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF DR
MDR report key: 2902586
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00359
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 20, 2012
- 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE LONGEVITY CALCULATION WAS NOT WITHIN EXPECTED LIMITS. WITH AN EXTERNAL POWER SUPPLY CONNECTED, THE DEVICE TESTED NORMALLY AND NO SOURCES OF HIGH CURRENT DRAIN WERE DETECTED. THE BATTERY WAS SENT TO THE MANUFACTURER AND NO INTERNAL ANOMALIES WERE DETECTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS UNDETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR AND THE NEXT DAY TRIGGERED END OF LIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9018 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |