FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1172121
·
Received September 18, 2008
Report
- Report Number
- 1644487-2008-02270
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT THE HANDHELD DISPLAYED AN ERROR MESSAGE UPON INTERROGATION. TROUBLESHOOTING WAS PERFORMED BUT DID NOT RESOLVE THE PROBLEM. ANOTHER HANDHELD WITH THE SAME WAND WAS USED WHICH RESOLVED THE ISSUE. THE PROBLEMATIC HANDHELD WAS SENT BACK TO THE MANUFACTURER FOR PRODUCT ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 523497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |