FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203126
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02503
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 18, 2008
- Report Date
- September 18, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THERE WAS AN ISSUE WITH THE HANDHELD DEVICE. THE SITE REPORTED THAT AN IMAGE WAS STUCK ON THE SCREEN. GOOD FAITH ATTEMPTS TO OBTAIN CLARIFICATION ON THE ISSUE FROM THE SITE HAVE BEEN UNSUCCESSFUL TO DATE. THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER BUT ANALYSIS IS NOT COMPLETE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 523496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |