FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1220046
·
Received October 31, 2008
Report
- Report Number
- 1644487-2008-02637
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE SITE THAT THEY HAD DIFFICULTY INTERROGATING THE PATIENT'S GENERATOR WHICH RESULTED IN AN UNKNOWN ERROR MESSAGE. THE NURSE PRACTITIONER ALSO REPORTED THAT THE PATIENT'S GENERATOR WAS FOUND TO BE AT 1.3 YEARS LEFT UNTIL END OF SERVICE. THEY INDICATED THAT THE PATIENT'S DEVICE WAS PROGRAMMED TO HIGH SETTINGS. THE SITE WAS CONCERNED THAT THE PATIENT'S GENERATOR MIGHT BE REACHING END OF SERVICE PREMATURELY WHEN COMPARED TO ANOTHER PATIENT'S DEVICE WITH SIMILAR SETTINGS AND GENERATOR MODEL. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HAVE BEEN UNSUCCESSFUL TILL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 1940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |