FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191491
·
Received September 26, 2008
Report
- Report Number
- 1644487-2008-02354
- Event Type
- Malfunction
- Date Received
- September 26, 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
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER THAT THE PHYSICIAN WAS HAVING DIFFICULTIES WITH THE PROGRAMMING SYSTEM. TROUBLESHOOTING WAS PERFORMED AND IT WAS REVEALED THAT THE SERIAL DATA CABLE WAS BELIEVED TO BE THE SOURCE OF THE PROBLEMS. THE HAND HELD AND THE CABLE HAVE BEEN RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 510179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |