FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1731633
·
Received June 10, 2010
Report
- Report Number
- 1644487-2010-01382
- Event Type
- Malfunction
- Date Received
- June 10, 2010
- Date of Event
- May 14, 2010
- Report Date
- May 14, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PROGRAMMING PHYSICIAN'S HANDHELD COMPUTER HAS BEEN CHARGING FOR SEVERAL DAYS BUT WHEN THEY TRIED TO TURN IT ON, IT WON'T TURN ON. GOOD FAITH ATTEMPTS TO HAVE THE HANDHELD COMPUTER RETURNED FOR PRODUCT ANALYSIS HAS BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 678297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |