FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1040827
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01106
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 8, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A HANDHELD WAS FREEZING DURING INTERROGATION. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND THE HANDHELD WAS SUBSEQUENTLY RETURNED TO MFR FOR ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND SOFTWARE, AND NO ANOMALIES THAT SUPPORT THE REPORTED COMPLAINT WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD AND SOFTWARE PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. DUE TO THIS, NO CONCLUSION CAN BE DRAWN REGARDING THE CAUSE OF THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |