FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1213123
·
Received October 23, 2008
Report
- Report Number
- 1644487-2008-02564
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 24, 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
INITIAL REPORTER INDICATED THAT HIS DELL HANDHELD CONTAINING 7.1 PROGRAMMING SOFTWARE FREEZES UPON INTERROGATION. THE SOFTWARE AND HANDHELD WERE RETURNED FOR PRODUCT ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE FLASHCARD AND NO ANOMALIES ASSOCIATED WITH THE FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. NO ANOMALIES NOTED WITH THE RETURNED HANDHELD IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |