FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1033147
·
Received April 22, 2008
Report
- Report Number
- 1644487-2008-00981
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTED PT SETTINGS CHANGED AFTER PERFORMING A SYSTEMS TEST. DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT AFTER RUNNING A SYSTEMS TEST THE HANDHELD WOULD CHANGE PT'S SETTINGS. THE HANDHELD HAD 7.1 PROGRAMMING SOFTWARE. THE HANDHELD AND SOFTWARE ARE AT THE MFR PENDING ANALYSIS COMPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 523499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |