FDA Adverse Event
Malfunction
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 4031725
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14760
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A TRANSMISSION FOR BACK UP VVI VIA MERLIN.NET. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE BACKUP VVI TRANSMISSION WAS INAPPROPRIATE. THE DEVICE WAS NOT FOUND IN BACK UP VVI. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508832 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |