FDA Adverse Event
Injury
Summary report: N
CURRENT DR
MDR report key: 3210671
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03285
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 23, 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 Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED UPON RECEIPT AND WAS DUE TO A POWER-ON RESET WHICH OCCURRED DURING HV THERAPY DELIVERY. AN ARC MARK WAS OBSERVED ON THE ICD CAN. FURTHER EVALUATION OF THE ARC MARK INDICATED THE PRESENCE OF LEAD MATERIAL. THE DAMAGE FOUND IS CONSISTENT WITH THAT CAUSED BY ARCING BETWEEN THE HV CONDUCTOR AND ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WENT INTO BACKUP VVI MODE AFTER CARDIOVERSION WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311812 | CURRENT DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2107-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | (B)(4) |