FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1854559
·
Received September 9, 2010
Report
- Report Number
- 1644487-2010-02059
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PHYSICIAN THAT HER HAND HELD SCREEN HAD A BLUE DISCOLORATION ON THE SCREEN, AND THERE WAS A LINE GOING ACROSS THE SCREEN. FOLLOW UP WITH THE SITE REVEALED THAT THEY WERE UNSURE HOW THE EVENT OCCURRED, BUT DID NOTE THAT THE DEVICE WAS FINE THE PREVIOUS DAY. THE HAND HELD AND SOFTWARE FLASHCARD HAVE BEEN RETURNED TO MANUFACTURER WHERE ANALYSIS IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 715911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |