FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL VR
MDR report key: 2243075
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06552
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 29, 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
- PA
- 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 ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED IN THE LABORATORY. THE DEVICE HAD HIGH CURRENT DRAIN THAT DEPLETED THE BATTERY. THE HIGH CURRENT WAS ISOLATED TO AN ANOMALOUS COMPONENT IN THE HYBRID SUBASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO EARLY BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT ACCEL VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |