FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1022716
·
Received March 26, 2008
Report
- Report Number
- 1644487-2008-00795
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE SERIAL CONNECTOR CABLE TO HIS VNS THERAPY PROGRAMMING HANDHELD WAS NOT OPERATING PROPERLY, IN THAT IT WAS LOOSE IN ITS CONNECTION WITH THE HANDHELD. HANDHELD AND CABLE WERE SUBSEQUENTLY RETURNED TO MANUFACTURER FOR ANALYSIS, HOWEVER, THAT ANALYSIS IS NOT YET COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 536291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |