FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 2242830
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06192
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 6, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS FOUND TO BE BELOW THE EXPECTED LONGEVITY LIMITS BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION. HIGH CURRENT WAS OBSERVED IN THE RF MODULE CIRCUITRY; THIS ANOMALY CAUSED THE PREMATURE BATTERY DEPLETION. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL BATTERY ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY VOLTAGE WAS EXCESSIVELY DISCHARGING FASTER THAN EXPECTED. THE DEVICE WILL BE EXPLANTED.
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED.
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 | 58 YR | Required Intervention |