BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1993851 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00248
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    September 8, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PT WAS DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS DUE TO INITIAL VNS IMPLANT SURGERY THAT OCCURRED ON (B)(6) 2010. THE PT HAS HAD AN INTERVENTION OF SILASTIC IMPLANTS PLACED INTO THE VOCAL CORD. THE PT IS SLOWLY IMPROVING AND RECEIVING VNS THERAPY AT THIS TIME. VNS DIAGNOSTICS TESTS WERE REPORTED TO BE WITHIN NORMAL LIMITS, BUT THE EXACT DATE AND RESULTS WERE NOT RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 2639

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention