FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203135
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02508
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- June 18, 2008
- Report Date
- September 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE SETTINGS WERE FOUND TO BE INCORRECT AT A FOLLOW-UP VISIT DUE TO A FAULT IN THE SYSTEM DIAGNOSTICS TEST AT THE PREVIOUS VISIT. A FINAL INTERROGATION WAS NOT PERFORMED BY THE PHYSICIAN AND THE SETTINGS WERE NOT FOUND TO BE INCORRECT UNTIL THE FOLLOW-UP VISIT AT WHICH TIME THE PT WAS REPROGRAMMED TO THE CORRECT SETTINGS. FOLLOW-UP REVEALED THAT THE PT'S DEVICE IS FUNCTIONING PROPERLY AND THERE HASN'T BEEN ANY INCREASE IN SEIZURE ACTIVITY DUE TO THE PROGRAMMING ANOMALY. NO FURTHER ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 584950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |