FDA Adverse Event
Malfunction
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 4221072
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17405
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- August 17, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
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, MULTIPLE VT/VF EPISODES WERE NOTED. SOME OF THE EPISODES WERE ENDED WITH ATP, ONE EPISODE REQUIRED A HIGH VOLTAGE SHOCK. THE SHOCK WAS INEFFECTIVE AND THE PATIENT RETURNED TO SINUS SPONTANEOUSLY BEFORE THE NEXT SHOCK. SOME PROGRAM CHANGES WERE RECOMMENDED. THE PATIENT WAS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702348 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1233-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |