FDA Adverse Event
Injury
Summary report: N
FORTIFY ST DR, DF4 CONNECTOR
MDR report key: 3080217
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-01007
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 28, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 FOLLOW UP, WHEN THE DEVICE FIRMWARE WAS BEING UPGRADED, THE COMMUNICATION WAND WAS DISPLACED AND THE UPGRADE PROCESS WAS INTERRUPTED. SHORTLY AFTER THIS OCCURRED, THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY. REVIEW OF THE ECG REVEALED THE INAPPROPRIATE THERAPY WAS DUE TO T-WAVE OVERSENSING. THE UPGRADE PROCESS WAS CONTINUED AND FULL FUNCTIONALITY OF THE DEVICE WAS RESTORED. THE OVERSENSING WAS NO LONGER DETECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182967 | FORTIFY ST DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |