FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1033463
·
Received April 23, 2008
Report
- Report Number
- 1644487-2008-00989
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEY WERE HAVING A "FROZEN SCREEN AFTER INTERROGATION. PHYSICIAN COULD NOT SWITCH THE COMPUTER OFF." THE DELL HANDHELD HAD 7.1 PROGRAMMING SOFTWARE. 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. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |