BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1891005 · Received October 29, 2010

    Report

    Report Number
    1644487-2010-02430
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X5 HANDHELD COMPUTER WITH 7.1 SOFTWARE WAS FREEZING DURING INTERROGATION OF A VNS PT. THE SCREEN FREEZING DID RESOLVE AFTER PERFORMING A HARD RESET AND INTERROGATION OF THE PT WAS THEN SUCCESSFUL. ALL ATTEMPTS TO HAVE THE SUSPECT COMPUTER RETURNED FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE. IT IS KNOWN THAT THE COMBINATION OF THE DELL X5 COMPUTER AND VERSION 7.1 SOFTWARE CAN CAUSE SCREEN FREEZING DURING INTERROGATION TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521411

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR