FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ST VR
MDR report key: 3892697
·
Received June 24, 2014
Report
- Report Number
- 2938836-2014-12387
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- April 20, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 PRESENTED FOR NORMAL FOLLOW-UP. DEVICE INTERROGATION SHOWED ERRONEOUS MESSAGES THAT THE PATIENT HAD RECEIVED MULTIPLE SHOCKS WHEN THERE WERE NO SHOCKS. A SUBSEQUENT INTERROGATION THE NEXT DAY SHOWED THAT THE DEVICE WAS IN BACKUP VVI MODE AND COULD NOT BE INTERROGATED FURTHER. THE DEVICE WAS REPROGRAMMED. DURING A FOLLOW-UP INTERROGATION TWO MONTHS LATER, ALL PARAMETERS WERE NORMAL AND THERE WERE NO FURTHER EPISODES. THE PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368640 | FORTIFY ST VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |