FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF-4 CONNECTOR
MDR report key: 3943925
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13520
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- July 2, 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
- TN, US
- Reporter Occupation
- NURSE
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 ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR FOLLOW-UP. POST-PACE T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423189 | 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 | 72 YR |