BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1213115 · Received October 23, 2008

    Report

    Report Number
    1644487-2008-02557
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN DEPRESSION. IT IS UNKNOWN WHETHER IT IS ABOVE OR BELOW THE PRE-VNS BASELINE. ALL ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR