FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1132728
·
Received August 21, 2008
Report
- Report Number
- 1644487-2008-01976
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- July 22, 2008
- Report Date
- July 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN (B) (4) COMPUTER WAS PRODUCING AN ERROR MESSAGE WHEN TRYING TO INTERROGATE A MODEL 103 DUMMY GENERATOR. THE SAME ERROR MESSAGE WAS NOT OBSERVED WHEN INTERROGATING A MODEL 102 DUMMY GENERATOR. RESETTING THE HANDHELD DID NOT RESOLVE THE ERROR MESSAGE. THE HANDHELD HAS BEEN RETURNED TO THE MANUFACTURER AND IS UNDERGOING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |