FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1023676
·
Received April 1, 2008
Report
- Report Number
- 1644487-2008-00826
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 6, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEIR DELL HANDHELD "SCREEN FREEZES UPON INTERROGATION AND REINSERTING THE FLASHCARD RESOLVES THE ISSUE AND IT REOCCURS." MFR IS PENDING RECEIPT OF THE PRODUCT FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |