FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1232732
·
Received November 14, 2008
Report
- Report Number
- 1644487-2008-02769
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FACILITY WAS EXPERIENCING PROBLEMS WITH THEIR HANDHELD COMPUTER. ADDITIONAL INFORMATION WAS PROVIDED AND REVEALED THAT A "CHECKSUM" ERROR MESSAGE WAS RECEIVED WHEN TRYING TO PERFORM AN INTERROGATION. USING A DIFFERENT WANT RESOLVED THE ISSUE AT THE TIME. HOWEVER, THE ISSUE WAS REPEATED AGAIN WITH THE SAME HANDHELD AND THE DIFFERENT WAND. GOOD FAITH ATTEMPTS TO OBTAIN THE PRODUCT FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |