BEUDAMED
    FDA Adverse Event Death Summary report: N

    FISHER WALLACE BRAIN STIMULATOR

    MDR report key: 4538850 · Received February 16, 2015

    Report

    Report Number
    MW5040804
    Event Type
    Death
    Date Received
    February 16, 2015
    Date of Event
    December 27, 2014
    Report Date
    February 16, 2015
    Manufacturer
    FISHER WALLACE
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A PSYCHIATRIST RECOMMENDED THE FISHER WALLACE STIMULATOR FOR MY HUSBAND'S DEPRESSION. MY HUSBAND HAD BEEN PREVIOUSLY TREATED SUCCESSFULLY FOR 24 YEARS WITH ANTIDEPRESSANTS. HE STARTED USING THE STIMULATOR AT THE END OF (B)(6) 2014. HE WAS TOLD BY THE PSYCHIATRIST THAT HE WOULD BE ABLE TO BE WEANED OFF HIS ANTIDEPRESSANT. ONCE HE WAS TOTALLY OFF THE ANTIDEPRESSANTS AND SOLELY USING THE STIMULATOR, HE EXPERIENCED EXTREME IRRITABILITY AND ANXIETY. THE WEEK BEFORE CHRISTMAS, HE STARTED EXPERIENCING EXTREME DEPRESSION AND SEVERE TIREDNESS. ON (B)(6) 2014, HE TOOK HIS OWN LIFE. I FEEL THAT THE REASON THAT HE TOOK HIS LIFE IS DUE TO THE FISHER WALLACE STIMULATOR AND THE FALSE CLAIMS OF HOW WELL IT WORKS FOR DEPRESSION. EACH PERSON HAS DIFFERENT TYPES OF DEPRESSION CAUSED BY MANY DIFFERENT REASONS. I DO NOT BELIEVE THAT THIS STIMULATOR IS SAFE AND EFFECTIVE ON JUST ANY PERSON DIAGNOSED WITH DEPRESSION. I ALSO BELIEVE THAT PATIENTS NEED TO BE CLOSELY SUPERVISED WHILE USING THIS PRODUCT. MY HUSBAND, SADLY, WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111349 FISHER WALLACE BRAIN STIMULATOR FISHER WALLACE BRAIN STIMULATOR JXK FISHER WALLACE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death