FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR, DF4 CONNECTOR
MDR report key: 3210419
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03390
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 18, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 DURING A FOLLOW UP AFTER THE PATIENT WENT THROUGH MRI SCAN, THE PHYSICIAN NOTED THE DEVICE WAS IN BACK UP VVI MODE. RESTORING THE SOFTWARE AND REPROGRAMMING RESOLVED THE ISSUE. ALL ELECTRICAL PARAMETERS ARE IN RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311350 | FORTIFY DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2233-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |