BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE WALKAIDE STIMULATOR SYSTEM

    MDR report key: 1441116 · Received August 3, 2009

    Report

    Report Number
    MW5012419
    Event Type
    Injury
    Date Received
    August 3, 2009
    Manufacturer
    INNOVATIVE NEUROTRONICS, INC.
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS PURCHASED IN 2009. PT WAS WEARING IT INITIALLY FOR 2 HOURS A DAY, THEN PROLONGED THE TIME OF USAGE TO SEVERAL HOURS A DAY (FOR ABOUT A MONTH). AT APPROX TWO MONTHS OF USAGE, THE SERIOUS HICCUPS ATTACK OCCURRED, AND PERSISTED FOR SEVERAL DAYS BEFORE WE CALLED THE EMERGENCY EXCHANGE - DR. AND PT WAS PRESCRIBED CHLORPROMAZINE 25 MG 1-2 3 TIMES DAILY. HE WAS TAKING THE DEVICE OFF FOR NIGHT, WHEN HE DID, ATTACK SLOWED A LITTLE. HE WAS SEEN ON EMERGENCY BY THE DR. THE HICCUPS PERSISTED BESIDES OF MEDICATION AND PT STARTED TO HAVE DIFFICULTY BREATHING. HE WAS SEEN ON EMERGENCY BY ANOTHER DR. AND WAS PRESCRIBED METOCLOPRAMIDE 10MG 1 TAB BEFORE NIGHT. WHEN HE CAME FROM APPOINTMENT WITH THE DR. HE TOOK WALKAIDE OFF PERMANENTLY AND HICCUPS SUBSIDED AFTER A DAY. ALSO BREATHING CAME BACK TO NORMAL. THAT VISIT WAS ONE WEEK AFTER THE OCCURRENCE. WE ARE CONVINCED THAT THIS ABOVE MENTIONED DEVICE CAUSED THOSE SERIOUS EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE WALKAIDE STIMULATOR SYSTEM WALKAIDE SYSTEM GZI INNOVATIVE NEUROTRONICS, INC. 20-0100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other