FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2181420
·
Received July 6, 2011
Report
- Report Number
- 1644487-2011-01512
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: NO MALFUNCTION ACTUALLY OCCURRED, AS LOCK BUTTON WAS ON, CAUSING ISSUE.
Description of Event or Problem · 1
HANDHELD DEVICE INFORMATION WAS OBTAINED FOR THE HANDHELD IN QUESTION. THERE WAS ALSO NO ACTUAL MALFUNCTION OF THE DEVICE AS THE LOCK BUTTON WAS JUST ON CAUSING THE ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING PROBLEMS WITH HER HANDHELD COMPUTER AND WANTED TO GET RID OF IT. THE PHYSICIAN DOES NOT CURRENTLY HAVE ANY VNS PTS ANYWAY. ATTEMPTS FOR FURTHER INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | 250 | 840144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |