FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2092177
·
Received April 27, 2011
Report
- Report Number
- 1644487-2011-00899
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 28, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT SHE RECEIVES AN ERROR MESSAGE WHEN THE HANDHELD IS TURNED ON. THE ERROR MESSAGE STATES THAT V7.1 SOFTWARE HAD NOT BEEN COMPLETELY UNINSTALLED. THE ERROR MESSAGE BEGAN APPEARING AFTER THE V8.0 UPGRADE. A NEW V8.0 FLASHCARD WAS USED TO UPGRADE THE HANDHELD AND THE PROBLEM HAS RESOLVED. THE ORIGINAL FLASHCARD HAS BEEN RETURNED TO THE MFR FOR EVAL. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 863935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |