FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA VR, DF-4 CONNECTOR
MDR report key: 4220976
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17452
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 19, 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
- CA
- 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 TO THE EMERGENCY ROOM WHEN RECEIVING A VIBRATORY ALERT. UPON INTERROGATION, NON SUSTAINED VENTRICULAR OVERSENSING OF WIDE QRS WAS PRESENT DURING ROUTINE CAPACITOR MAINTENANCE CHARGING. DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702536 | FORTIFY ASSURA VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1259-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |