FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1232726
·
Received November 14, 2008
Report
- Report Number
- 1644487-2008-02764
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 16, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS THERAPY PROGRAMMING HANDHELD WAS "LOCKING UP, NOT COMMUNICATING WHILE IN THE OR." THE HANDHELD HAS BEEN RETURNED TO THE MANUFACTURER AND IS PENDING ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |