FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1111876
·
Received August 12, 2008
Report
- Report Number
- 1644487-2008-01878
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE PT'S VNS WAS INTERROGATED AND FOUND TO BE SET TO 0MA. THE PT HAD BEEN AT A AMUSEMENT PARK AND SINCE THAT TIME COULD NOT FEEL STIMULATION. THE PT ALSO REPORTED MILD PAIN OVER HER GENERATOR SITE FROM A RIDE AT THE PARK. THE VNS WAS PROGRAMMED BACK ON AND THE PT DID NOT REPORT ANY PAIN. IT IS UNK IF A PREVIOUS DIAGNOSTIC TEST WAS INTERRUPTED CHANGING THE PT'S SETTINGS. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |