BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1212557 · Received October 27, 2008

    Report

    Report Number
    1644487-2008-02595
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    July 28, 2008
    Report Date
    October 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PATIENT HAD LEFT VOCAL CORD PARALYSIS AND HOARSENESS NOTED IMMEDIATELY ON IMPLANT DATE. IT WAS ALSO NOTED THAT THERE WAS TETHERING OF THE LEAD SO THAT IT STRETCHES, IS VISIBLE WITH THE CHIN TILTED UP. THE PATIENT'S VNS IS CURRENTLY PROGRAMMED ON AND THEY ARE RECEIVING SPEECH THERAPY FOR THEIR LEFT VOCAL CORD PARALYSIS. THE VOCAL CORD PARALYSIS IS BEING RELATED TO THEIR IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other