FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1033469
·
Received April 23, 2008
Report
- Report Number
- 1644487-2008-00993
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
RPTR INDICATED THAT A DELL X5 VNS HANDHELD COMPUTER WOULD NOT POWER ON. THE NEXT DAY, IT PERFORMED AS EXPECTED. THE HANDPIECE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 544025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |