FDA Adverse Event
Malfunction
Summary report: N
PROGRAMING SOFTWARE
MDR report key: 1172118
·
Received September 18, 2008
Report
- Report Number
- 1644487-2008-02257
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 18, 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
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT HIS DELL X5 HANDHELD COMPUTER "KEPT FREEZING UPON INTERROGATION". ALL ATTEMPTS FOR FURTHER INFORMATION ARE PENDING. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |