BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1953677 · Received January 4, 2011

    Report

    Report Number
    1644487-2011-02962
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    August 3, 2007
    Report Date
    December 7, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT DEVELOPED LEFT VOCAL CORD PARALYSIS DUE TO INITIAL VNS IMPLANT SURGERY PERFORMED ON (B)(6) 2007. THE PATIENT HAD A SILASTIC IMPLANT IN THE LEFT VOCAL CORD PERFORMED IN 2008, AND RECENTLY HAD THIS REPLACED WITH A GORE-TEX IMPLANT. THE PATIENT ALSO HAD LEFT VOCAL CORD MEDIALIZATION SURGERY PERFORMED ON (B)(6) 2010. THE PATIENT CAN NOW PROJECT HER VOICE AND SPEAKING IS NOT AS TIRING, AND HER VOICE HAS MUCH IMPROVED BUT IS STILL HOARSE. THE PATIENT HAS EXCELLENT MOBILITY CURRENTLY WITH BOTH VOCAL CORDS, WITH COMPLETE GLOTTIC CLOSURE. THE PATIENT'S VNS WAS DISABLED ON (B)(6) 2009, DUE TO NECK PAIN, AND THE GENERATOR AND MOST OF THE LEAD WAS EXPLANTED ON (B)(6) 2010, DUE TO PAIN IN THE CHEST (REPORTED PREVIOUSLY VIA MDR # 1644487-2010-02741). ALL ATTEMPTS FOR RETURN OF THE EXPLANTED LEAD AND GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 200228

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention