BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16861992 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00012
    Event Type
    Injury
    Date Received
    May 3, 2023
    Report Date
    December 30, 2022
    Manufacturer
    FISHER WALLACE LABS
    Product Code
    QJQ
    PMA / PMN Number
    K903654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT INFORMATION: "I ACTUALLY DID HAVE SOME ADVERSE REACTIONS AND HAD TO STOP USING IT. ALTHOUGH I HAD AN IMPROVEMENT OF MENTAL SYMPTOMS THE FIRST DAY, I DID HOWEVER HAVE PROLONGED CHEST PAIN FOLLOWING THE USE OF IT. I COULD ONLY USE IT FOR ONE DAY BECAUSE IF I CONTINUED THE USE OF IT, I WOULD CONTINUE TO HAVE CHEST PAIN AND WORSE HEART PALPITATIONS-IRREGULAR HEARTBEAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533806 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other