FDA Adverse Event
Injury
Summary report: N
CURRENT VR RF CD-1211-36Q
MDR report key: 1590936
·
Received January 26, 2010
Report
- Report Number
- MW5014550
- Event Type
- Injury
- Date Received
- January 26, 2010
- Date of Event
- November 23, 2009
- Report Date
- January 26, 2010
- Manufacturer
- ST JUDE
- Product Code
- MTE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING DEFIBRILLATION TESTING, VENTRICULAR FIBRILLATION WAS INDUCED BY THE ST JUDE FIBBER. VENTRICULAR FIBRILLATION WAS SEEN ON THE ST JUDE PROGRAMMER. DURING EVENT, WITHOUT WARNING, THERE WAS A LOSS OF TELEMETRY AND FAILURE OF THE IMPLANTABLE DEFIBRILLATOR TO DELIVER THERAPY. PT HAD TO BE EXTERNALLY DEFIBRILLATED. NO ADVERSE EVENT OCCURRED TO THE PT. DEVICE WAS FOUND TO BE IN VVI RESET MODE, AND COULD NOT BE INTERROGATED. NEW DEVICE WAS IMPLANTED IN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT VR RF CD-1211-36Q | DEFIBRILLATOR | MTE | ST JUDE | CURRENT VR | 565410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Life Threatening |