FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1181591
·
Received September 25, 2008
Report
- Report Number
- 1644487-2008-02336
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A SQL ERROR WAS RECEIVED WHEN ATTEMPTING TO UPLOAD A VNS FLASHCARD. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND THE CAUSE FOR THE SQL ERROR MESSAGE IS ASSOCIATED WITH A CORRUPT CYBERONICS (B) (4) DATABASE. NO ROOT CAUSE FOR THE DATABASE CORRUPTION COULD BE DETERMINED BASED ON THE RETURNED FLASHCARD AND SOFTWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 366985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |