BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1015572 · Received March 19, 2008

    Report

    Report Number
    1644487-2008-00734
    Event Type
    Injury
    Date Received
    March 19, 2008
    Date of Event
    November 22, 2007
    Report Date
    February 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PT IS EXPERIENCING MANIA. THE PT HAS A HISTORY OF MANIA. IT WAS ALSO REPORTED THE PT HAS BEEN DIAGNOSED AS BI-POLAR SINCE BEING IMPLANTED THE VNS THERAPY. THE PT HAS REPORTEDLY NOT EXPERIENCED ANY LIFE CHANGING EVENTS. THE PT HAS BEEN ON MAO'S (MONOAMINE OXIDASE INHIBITORS), LITHIUM, WELLBUTRIN AND LEXAPRO. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK MUZ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other