FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ST VR, DF4 CONNECTOR
MDR report key: 3080166
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00997
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- March 4, 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. THE DEVICE WAS LATER RESTORED TO INITIAL PROGRAMMING AND THE SOFTWARE UPGRADE WAS PERFORMED SUCCESSFULLY.
Description of Event or Problem · 1
IT WAS REPORTED THT DURING A FOLLOW UP, DURING DEVICE INTERROGATION AN ALERT FOR SOFTWARE UPGRADE WAS RECOMMENDED MESSAGE WAS OBSERVED. AFTER THE UPGRADE WAS INITIATED THE PATIENT RECEIVED A SHOCK. THE PROGRAMMER WAS REMOVED, HOWEVER, THE PATIENT RECEIVED ANOTHER SHOCK AND A MAGNET WAS PLACED OVER THE ICD. THE DEVICE WAS FOUND IN A BACKUP VVI RESET MODE AND ABORTED UPGRADE. THE PATIENT RECEIVED MULTIPLE SHOCKS THEREAFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181006 | FORTIFY ST VR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |