BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1202924 · Received October 17, 2008

    Report

    Report Number
    1644487-2008-02505
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED VOCAL CORD PARALYSIS AS A RESULT OF VNS. THE PT WENT TO A SURGEON FOR A CONSULTATION, AND THE SURGEON PROGRAMMED THE PT'S DEVICE OFF. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 1898C

    Patients

    Seq Age Sex Outcome Treatment
    1