BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1022725 · Received March 27, 2008

    Report

    Report Number
    1644487-2008-00812
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A DELL HANDHELD COMPUTER HAS BEEN "FREEZING UP." TROUBLESHOOTING WAS REPORTED TO "SOMETIMES" RESOLVE THE EVENT. GOOD FAITH ATTEMPTS FOR ADD'L INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1