FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF-4 CONNECTOR
MDR report key: 3943934
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13425
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 4, 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
- CO, 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 VIA REMOTE TRANSMISSION, POST-PACED T WAVE OVERSENSING WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AND THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423192 | FORTIFY ASSURA DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |