FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA ST VR
MDR report key: 4220894
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17453
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 15, 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 UPON INTERROGATION, PREVIOUS EPISODES OF NON-SUSTAINED OVERSENSING DUE TO NOISE WERE OBSERVED. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. PROGRAMMING CHANGE WAS MADE. PATIENT CONDITION WAS GOOD.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT NON-SUSTAINED OVERSENSING EPISODES WERE OBSERVED. PROGRAMMING CHANGES WERE MADE. THE PATIENT WILL CONTINUE TO BE MONITORED CLOSELY. PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702199 | FORTIFY ASSURA ST VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1359-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |