FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1052925
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01199
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT HIS VNS THERAPY PROGRAMMING HANDHELD WAS NOT OPERATING PROPERLY. NO OTHER SPECIFICS ARE AVAILABLE TO MFR AT THIS TIME. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |