FDA Adverse Event
Injury
Summary report: N
CURRENT RF VR
MDR report key: 1073489
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02268
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE. THE BATTERY VOLTAGE WAS FOUND TO BE VERY LOW. AN OPEN CIRCUIT ON THE HYBRID SUBASSEMBLY CAUSED CURRENT DRAINAGE, WHICH LED TO THE PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED ERI PREMATURELY AFTER ONLY FOUR MONTHS OF IMPLANT. THE PATIENT HAS SINCE BEEN LOST TO FOLLOW-UP. IT IS UNKNOWN IF THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |