FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1181592
·
Received September 25, 2008
Report
- Report Number
- 1644487-2008-02345
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 29, 2008
- Report Date
- August 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A VNS DELL X50 HANDHELD COMPUTER WAS NOT PERFORMING AS INTENDED. THE COMPUTER WAS ALSO NOT CHARGED PER THE REPORTER. THE REPORTER WAS ADVISED TO FULLY CHARGE THE COMPUTER BEFORE THE NEXT USE. ATTEMPTS TO THE REPORTER TO ASCERTAIN WHETHER THE COMPUTER WAS WORKING PROPERLY AFTER CHARGING HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 584949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |