BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA STIM

    MDR report key: 486996 · Received August 24, 2003

    Report

    Report Number
    MW1029543
    Event Type
    Other
    Date Received
    August 24, 2003
    Date of Event
    August 23, 2003
    Report Date
    August 24, 2003
    Manufacturer
    ELECTROMEDICAL PRODUCTS INT. 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

    ADD'L INFO REC'D FROM MFR 10/29/03: CONCLUSION: THIS SYMPTOM HAS NEVER BEEN REPORTED PREVIOUSLY IN THE 22 YEARS THIS TECHNOLOGY HAS BEEN ON THE MARKET, OR IN ANY RESEARCH STUDY ON THESE, OR ANY OTHER CRANIAL ELECTROTHERAPY STIMULATOR. IT IS PROBABLE THAT THIS PT, WHO IS EVIDENTLY DIAGNOSED AS HAVING AN ATTENTION DEFICIT DISORDER (ADD), HAD ANXIETY OVER THE USE OF THIS DEVICE WHICH CAUSED THEM TO EXPERIENCE THE "ODD SENSATION IN CHEST" THAT WAS REPORTED. THE REPORTING PHYSICIAN DID NOT CONSIDER THE REPORTED EVENT SIGNIFICANT ENOUGH TO REQUIRE ANY FURTHER DIAGNOSTIC WORK-UP OR THERAPY. FURTHER, THE PT HAS NOT EXPERIENCED ANY PERMANENT IMPAIRMENT OF ANY BODY FUNCTION IN THE TWO MONTHS SINCE THIS PROBLEM WAS REPORTED. ACCORDINGLY, NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING TRIAL OF CRANIAL ELECTRO STIMULATIN FOR ADD PT, OBSERVED EFFECT AT LOW SETTINGS. AFTER ABOUT 3-5 MINUTES AN ODD SENSATION IN THE CHEST WAS EXPERIENCED. THIS STOPPED IMMEDIATELY WHEN THE STIMULATION WAS REMOVED. NO FURTHER USE OF THE MACHINE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other