BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1022079 · Received March 28, 2008

    Report

    Report Number
    1644487-2008-00819
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HE WAS HAVING TROUBLE WITH THE SERIAL ADAPTER CABLE TO HIS VNS THERAPY PROGRAMMING HANDHELD, IN THAT IT FIT LOOSELY. GOOD FAITH ATTEMPTS FOR THE RETURN OF THE HANDHELD ARE CURRENTLY BEING MADE.

    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