FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF-4 CONNECTOR
MDR report key: 3901083
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12686
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- April 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
- VA, 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 PATIENT PRESENTED IN-CLINIC FOR A NORMAL FOLLOW-UP. REVIEW OF THE EGMS REVEALED DEVICE WAS FAR R-WAVE OVERSENSING ON THE ATRIAL CHANNEL. PROGRAMMING CHANGES WERE MADE. PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381286 | FORTIFY ASSURA DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2357-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |