FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 952810
·
Received April 26, 2007
Report
- Report Number
- 1644487-2007-00233
- Event Type
- Malfunction
- Date Received
- April 26, 2007
- Date of Event
- January 1, 2007
- Report Date
- February 2, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE CONFIRMED IN PA, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE POWER CORD FOR THE HAND HELD COMPUTER WAS "SHORTED OUT" THAT THE SCREEN WAS "MESSED UP". THE HAND HELD WAS RETURNED TO CYBERONICS INC. FOR ANALYSIS. THE ANALYSIS REVEALED THAT THE AC ADAPTER WAS DAMAGED, SHOWING A PORTION OF THE CONNECTOR MISSING. IT WAS IDENTIFIED THAT THE SUPPORT LAB (NOT RETURNED) OF THE TERMINALS BROKE-OFF FROM THE CONNECTOR. THIS WAS MOST LIKELY THE RESULT OF THE FORCE EXERTED BY USER HANDLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | LYJ | CYBERONICS, INC. | MODEL 250 | 162249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |