BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA-STIM 100

    MDR report key: 486965 · Received August 24, 2003

    Report

    Report Number
    MW1029542
    Event Type
    Other
    Date Received
    August 24, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 24, 2003
    Manufacturer
    ELECTROMEDICAL PRODUCTS INTERNATIONAL INC.
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USING ALPHA STIM MICROCURRENT FOR PAIN CONTROL IN A PT WITH FIBROMYALGIA AND SEIZURE DISORDER. THE PT HAD A HEADACHE. THE MICROCURRENT WAS BEING TRIED TO SEE IF THIS PT WOULD HAVE A FAVORABLE RESPONSE AS SEVERAL OTHER FIBROMYALGIA PTS HAVE EXPERIENCED. INSTEAD THE HA GOT WORSE. THE PT HAD INCREASE IN SEIZURE ACTIVITIY AND ALSO DEPRESSION - OFTEN OCCURRING WITH THE INCREASED SEIZURE ACTIVITY IN THE PAST- THEIR SPOUSE REPORTED THIS. ADDITION OF A SECOND ANTISEIZURE MEDICATION WAS NECESSARY TO RETURN CONTROL AS WELL AS SHIFT IN ANTI DEPRESSANT. TWO OTHER EVENTS OCCURRED DURING THIS TIME PER THE PT. IT WAS THE ANNIVERSARY OF SEVERAL IMPORTANT DEATHS FOR THE PT. SECONDLY FOREST FIRES AND SMOKE CAUSING SEVERE RESPIRATORY PROBLEMS, THAT REQUIRED HOSPITALIZATION AND TESTING FOR MI ALSO OCCURRED IN THE WEEKS OF THE INCREASED SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA-STIM 100 MICROCURRENT JXK ELECTROMEDICAL PRODUCTS INTERNATIONAL INC. ALPA-STIM 100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other