FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1232719
·
Received November 14, 2008
Report
- Report Number
- 1644487-2008-02752
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE SITE'S PROGRAMMING SYSTEM WAS "NOT WORKING HALF THE TIME." AFTER BEING CHANGED, THE HANDHELD COMPUTER WOULD OFTEN NOT TURN ON AND NONE OF THE TROUBLESHOOTING RESOLVED THE PROBLEM. PRODUCTS WERE RETURNED TO THE MANUFACTURER, BUT ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 584954 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |