FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL VR
MDR report key: 3210439
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03348
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 7, 2013
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF BACKUP VVI RESET MODE WAS CONFIRMED IN THE LABORATORY. THE RESET WAS CAUSED BY A POWER-ON RESET WHICH OCCURRED DURING HIGH VOLTAGE THERAPY DELIVERY. X-RAY INSPECTION OF THE DEVICE FOUND A BROKEN CAN WIRE. IT IS BELIEVED THAT THE DEVICE WENT INTO RESET DURING HIGH VOLTAGE THERAPY DELIVERY DUE TO THE BROKEN WIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW UP, HIGH HV LEAD IMPEDANCE WAS OBSERVED. DURING DFT TESTING THE DEVICE FAILED TO CONVERT AND THE PATIENT WAS DEFIBRILLATED EXTERNALLY. THE DEVICE WAS FOUND IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310694 | CURRENT ACCEL VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |