BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR

    MDR report key: 4217183 · Received October 26, 2014

    Report

    Report Number
    MW5038867
    Event Type
    Injury
    Date Received
    October 26, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 26, 2014
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE FISHER WALLACE STIMULATOR AS A TREATMENT FOR DEPRESSION, CHRONIC PAIN, ANXIETY AND INSOMNIA. MY FIRST TREATMENT WAS (B)(6) 2014. IMMEDIATELY AFTER THE TREATMENT ENDED, I DEVELOPED A SEVERE HEADACHE IN MY TEMPLES AND ACROSS MY FOREHEAD THAT HAS NOT DIMINISHED AS OF (B)(6) 2014. THE DOCUMENTATION INCLUDED WITH THIS DEVICE WARNED OF A POSSIBLE MILD HEADACHE IN THE AREA OF THE CONDUCTOR PADS DURING THE TREATMENT, BUT THE HEADACHE WOULD END WHEN THE TREATMENT ENDED AND THIS MILD HEADACHE WAS RARE. I HAVE RETURNED OF ANY KIND. I FOLLOWED THE INSTRUCTIONS OF THE DOCUMENTATION TO THE LETTER AND WATCHED THE VIDEO DEMO ON THE FISHER WALLACE WEBSITE AS WELL. I HAD EVERY EXPECTATION THAT I WOULD HAVE NO SERIOUS SIDE EFFECTS. I HAVE NOT CONTACTED FISHER WALLACE TO REPORT THE PROBLEM AS I AM NOT AWARE THEY HAVE A TRAINED MEDICAL PRACTITIONER AVAILABLE FOR CONSULTATION. I HAVE NO IDEA HOW LONG THIS HEADACHE MAY LAST AND I HAVE NO RECOURSE OTHER THAT A REFUND FOR THE PURCHASE PRICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680947 STIMULATOR STIMULATOR JXK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other