FDA Adverse Event
Injury
Summary report: N
FORTIFY ST DR, DF4 CONNECTOR
MDR report key: 3080227
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-01005
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 5, 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 SOFTWARE WAS BEING UPGRADED, TELEMETRY WAS LOST AND INAPPROPRIATE THERAPY WAS DELIVERED. THE PATIENT WAS IN SINUS RHYTHM DURING THE UPDATE. A SECOND ATTEMPT AT UPGRADE WAS SUCCESSFUL. THE PHYSICIAN SUSPECTS THE DEVICE WENT INTO BACKUP VVI MODE AND THE DEVICE OVERSENSED T WAVES. PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182857 | 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 |