FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1220051
·
Received October 31, 2008
Report
- Report Number
- 1644487-2008-02642
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 2, 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 THAT THERE WAS A PROBLEM WITH THE SOFTWARE DUE TO AN SQL ERROR APPEARING WILE TRYING TO UPLOAD THE INFO FROM THE FLASHCARD. PRODUCT ANALYSIS WAS PERFORMED AND AN SQL ERROR WAS FOUND INDICATING THAT THE DATABASE WAS CORRUPT. NO FURTHER ANOMALIES WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS INC | MODEL 250 | 366950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |