FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFRWARE
MDR report key: 1132733
·
Received August 22, 2008
Report
- Report Number
- 1644487-2008-01991
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- March 6, 2007
- Report Date
- July 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT WAS INTERROGATED AND FOUND TO BE AT UNINTENDED SETTINGS AND HAD EXPERIENCED AN INCREASE IN SEIZURES BELOW PRE-VNS BASELINE. A REVIEW OF PROGRAMMING HISTORY REVEALED THAT A SYSTEM DIAGNOSTICS TEST HAD FAULTED IN 2007, AND THE PATIENT WAS INTERROGATED AND LEFT AT SYSTEM DIAGNOSTICS SETTINGS. ALTHOUGH THE PHYSICIAN INDICATED THAT THE PATIENT WAS AT THE INTENDED SETTINGS IN 2007, THESE SETTINGS MAY HAVE NEVER BEEN CORRECTED. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFRWARE | LYJ | CYBERONICS, INC. | 250 | 521418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |