BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1190793 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02290
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE SERIAL ADAPTER CABLE ON THE PHYSICIANS' HAND HELD HAD A LOOSE CONNECTION AND THE DEVICE WOULD NOT WORK PROPERLY UNLESS THE CORD WAS HELD IN A CERTAIN POSITION. A NEW HAND HELD WAS SENT TO REPLACE THE NON-WORKING DEVICE. THE NON-WORKING HAND HELD AND SERIAL ADAPTER CABLE HAVE BEEN RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521405

    Patients

    Seq Age Sex Outcome Treatment
    1