FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1052239
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01212
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE SITES HAND HELD BECAME FROZEN FOLLOWING INTERROGATION OF VNS PT'S DEVICES. THE FLASHCARD WAS REMOVED AND RE-INSERTED TO RESOLVE THE FROZEN SCREEN. THE SITE REQUESTED A NEW HAND HELD AND FLASHCARD BE SENT TO REPLACE THE NON-WORKING DEVICE. ATTEMPTS TO OBTAIN THE NON-WORKING DEVICE FOR ANALYSIS HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS, INC. | 250 | 521373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |