BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16861994 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00011
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    November 17, 2022
    Report Date
    March 24, 2023
    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

    INITIAL: "I STARTED ON LEVEL 2 ON 11/17 AND MISCALCULATED AND STARTED YESTERDAY ON LEVEL 4. SINCE THEN MY ANXIETY HAS BEEN MUCH WORSE. HELP!!!" EVENT DETAILS: I WENT FROM 2 TO THE 4, AND IT WAS A LITTLE INTENSE AND I REACHED OUT TO SUPPORT. I THINK THEY SAID GO TO 2 OR 3, I MIGHT'VE WENT BACK TO 2. I DID EVENTUALLY WENT TO 3 AND DID THAT FOR A FEW DAYS, AND THEN ONCE I WENT TO 4, IT WASN'T INTENSE ANYMORE. SO ITS FUNNY, AROUND THAT TIME (GOING TO LEVEL 4), I WAS TRYING A DIFFERENT MEDICINE AT THE SAME TIME, AND I THOUGHT THE MEDICINE HAD BEEN THE OPTION THAT WORKED BUT IT WASN'T. IT WAS THE HEADSET AND AT THAT TIME I ALREADY RETURNED IT. CUZ I WENT LIKE, 3-4 DAYS WITHOUT IT. AND ONE DAY I JUST FELT GREAT, REALLY NORMAL. SO I THOUGHT IT WAS THE MEDICINE. THEN I HAD TO GO TO A DINNER, AND I FELT THE ANXIETY COMING BACK. SO I THOUGHT IT WAS THE HEADSET. SO SHORT STORY, I GOT THE DEVICE AGAIN, A FEW WEEKS AGO - FEBRUARY 24TH I STARTED USING IT AGAIN. I DID TWO WEEKS ON LEVEL 2, I USED IT TWICE A DAY, 20 MINUTES A DAY, JUST AS DIRECTED. THEN ON THE 10TH, I STARTED LEVEL 3 THIS TIME. SO ON THE 18TH, I STARTED ON LEVEL 4. NOTHING YET. BUT I EVENTUALLY GOT HEART PALPITATIONS AND I DIDN'T GET DOCTOR SUPPORT, SO I RETURNED. INITIAL: "I STARTED ON LEVEL 2 ON (B)(6) AND MISCALCULATED AND STARTED YESTERDAY ON LEVEL 4. SINCE THEN MY ANXIETY HAS BEEN MUCH WORSE. HELP!!!" EVENT DETAILS: I WENT FROM 2 TO THE 4, AND IT WAS A LITTLE INTENSE AND I REACHED OUT TO SUPPORT. I THINK THEY SAID GO TO 2 OR 3, I MIGHT'VE WENT BACK TO 2. I DID EVENTUALLY WENT TO 3 AND DID THAT FOR A FEW DAYS, AND THEN ONCE I WENT TO 4, IT WASN'T INTENSE ANYMORE. SO ITS FUNNY, AROUND THAT TIME (GOING TO LEVEL 4), I WAS TRYING A DIFFERENT MEDICINE AT THE SAME TIME, AND I THOUGHT THE MEDICINE HAD BEEN THE OPTION THAT WORKED BUT IT WASN'T. IT WAS THE HEADSET AND AT THAT TIME I ALREADY RETURNED IT. CUZ I WENT LIKE, 3-4 DAYS WITHOUT IT. AND ONE DAY I JUST FELT GREAT, REALLY NORMAL. SO I THOUGHT IT WAS THE MEDICINE. THEN I HAD TO GO TO A DINNER, AND I FELT THE ANXIETY COMING BACK. SO I THOUGHT IT WAS THE HEADSET. SO SHORT STORY, I GOT THE DEVICE AGAIN, A FEW WEEKS AGO - FEBRUARY 24TH I STARTED USING IT AGAIN. I DID TWO WEEKS ON LEVEL 2, I USED IT TWICE A DAY, 20 MINUTES A DAY, JUST AS DIRECTED. THEN ON THE 10TH OF MARCH, I STARTED LEVEL 3 THIS TIME. SO ON THE 18TH, I STARTED ON LEVEL 4. NOTHING YET. BUT I EVENTUALLY GOT HEART PALPITATIONS AND I DIDN'T GET DOCTOR SUPPORT, SO I RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533808 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other