FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR, DF4 CONNECTOR
MDR report key: 2984500
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00538
- Event Type
- Malfunction
- Date Received
- February 28, 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 THE PATIENT WENT INTO VT AND THE DEVICE DID NOT TERMINATE. AFTER SEVERAL FAILED THERAPIES, THE VT TERMINATED SPONTANEOUSLY. THE PHYSICIAN PROGRAMMED THE DEFT RESPONSE SETTINGS AND AFTER INDUCTION , THE DEVICE TERMINATED THE VF. PATIENT WAS IN GOOD CONDITION POST-EVENT. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87858 | 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 |