BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1810728 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00585
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A HANDHELD COMPUTER FREEZES FOLLOWING INTERROGATION. TROUBLESHOOTING WAS REPORTED TO BE UNABLE IN RESOLVING THE ISSUE. GOOD FAITH ATTEMPTS FOR RETURN OF THE DEVICE HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE NONE LYJ CYBERONICS, INC. 250

    Patients

    Seq Age Sex Outcome Treatment
    1