FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2081459
·
Received April 20, 2011
Report
- Report Number
- 1644487-2011-00850
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO OUR COUNTRY MANAGER IN (B)(4) FROM A VNS TREATING PHYSICIAN THAT THEIR HANDHELD COMPUTER CONTAINING 8.0 PROGRAMMING SOFTWARE WOULD NOT PROGRAM PTS. THE ERROR MESSAGE 0342 WAS REPORTED. THIS IS UNDER INVESTIGATION. THE MANUFACTURER IS PENDING THE HANDHELD AND SOFTWARE BEING RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 857134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |