FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1223464
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03644
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. THE FIELD EXPERIENCE OF PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE BATTERY VOLTAGE WAS FOUND TO BE 1.69V WHEN THE DEVICE WAS CUT OPEN. THE DEVICE WAS TESTED IN THE AUTOMATED ELECTRICAL TEST SYSTEM. THE TEST DETECTED NO ANOMALY AND THE DEVICE MET ALL OTHER SPECIFICATIONS. NORMAL DEVICE CURRENT WAS MEASURED. THE BATTERY WAS RETURNED TO THE SUPPLIER FOR FURTHER ANALYSIS. NO ANOMALY WAS DETECTED WITH THE BATTERY CELL. THE CAUSE OF THE LOW BATTERY VOLTAGE WAS NOT DETERMINED.
Description of Event or Problem · 1
THE DEVICE PRESENTED WITH A BATTERY AT EOS. 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 | Required Intervention |