BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA-STIM TECHNOLOGY

    MDR report key: 3532948 · Received December 19, 2013

    Report

    Report Number
    MW5033542
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    June 23, 2013
    Report Date
    December 19, 2013
    Manufacturer
    EPI, INC
    Product Code
    JXK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE REACTION TO ALPHA-STIM ELECTRODE. HE STATED HE USED THIS DEVICE AS TREATMENT FOR A PHOBIA OF FLYING. HE TRIED IT ON (B)(6) 2013, AND SAID HE FOLLOWED THE DIRECTIONS AND TRIED THE DEVICE AT THE MINIMUM CURRENT FOR THE MINIMUM AMOUNT OF TIME, WHICH IS 20 MINUTES. SINCE HE USED THE DEVICE, HE HAS BEEN EXPERIENCING SEVERE TINNITUS. HE STATED IT'S BEEN 6 MONTHS AND HE STILL HAS THE TINNITUS AND HE DOESN'T KNOW WHAT TO DO. HE STATED IT'S RUINING HIS LIFE. HE SAID HE'S TRIED ACUPUNCTURE, AND VISITED AN ENT DOCTOR TO HELP HIS CONDITION, BUT NOTHING IS HELPING AND THE DOCTOR DIDN'T FIND ANY PROBLEMS. HE SAID HE FEELS THE COMPANY LIED TO HIM AND THAT TINNITUS WAS NOT LISTED AS A POSSIBLE SIDE EFFECT WHEN USING THE DEVICE. HE MENTIONED THAT HE IS CONSIDERING CONTACTING A LAWYER BECAUSE HE DOESN'T KNOW WHAT ELSE TO DO. HE ALSO STATED HE READ INFO ON THE INTERNET, THAT IT HAS BEEN REPORTED TO THE FDA THAT PEOPLE HAVE EXPERIENCED TINNITUS USING THIS DEVICE. HE IS VERY UPSET THIS IS NOT LISTED AS A POSSIBLE SIDE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665702 ALPHA-STIM TECHNOLOGY ELECTRODE JXK EPI, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR