BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1181596 · Received September 25, 2008

    Report

    Report Number
    1644487-2008-02337
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS RECEIVING A "NEW APPLICATION NOT INSTALLED" ERROR MESSAGE WHEN SHE TRIED TO USE THE HANDHELD. SHE WAS UNABLE TO RESOLVE THE ISSUE THROUGH ROUTINE TROUBLESHOOTING. THE HANDHELD DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS AND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION PROCESS. AS A RESULT, NO LIKELY CAUSE FOR THE REPORTED CONDITION COULD BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521398

    Patients

    Seq Age Sex Outcome Treatment
    1