FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1213766
·
Received October 22, 2008
Report
- Report Number
- 1644487-2008-02556
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS THERAPY PROGRAMMING HANDHELD SCREEN WAS FREEZING AFTER INTERROGATION. THE PROGRAMMING HANDHELD HAS BEEN RETURNED TO THE MFR AND IS PENDING PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |