BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1071688 · Received July 8, 2008

    Report

    Report Number
    1644487-2008-01547
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 9, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE EXPERIENCED PROBLEMS WITH A FROZEN HAND HELD SCREEN. ADDITIONAL INFO WAS RECEIVED THAT INDICATED THE FROZEN SCREEN WOULD OCCUR FOLLOWING INTERROGATION AND WOULD TEMORARILY RESOLVE FOLLOWING FLASHCARD RE-INSERTION. ATTEMPTS TO OBTAIN THE NON-WORKING DEVICE FOR ANALYSIS HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521373

    Patients

    Seq Age Sex Outcome Treatment
    1