BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAINSWAY TMS MACHINE

    MDR report key: 16336244 · Received February 8, 2023

    Report

    Report Number
    MW5114794
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    June 15, 2022
    Report Date
    February 6, 2023
    Manufacturer
    BRAINSWAY LTD.
    Product Code
    OBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I STARTED TREATMENT ON (B)(6) 2022 FOR TMS. I STOPPED TREATMENT ON (B)(6) 2022 BECAUSE I BECAME SUICIDAL AND COULDN'T SLEEP. THE DOCTOR'S OFFICE WAS DIFFICULT TO GET A HOLD OF. THEY HAD A SERVICE IN INDIA ANSWERING PHONES. THEY LIED TO ME OVER AND OVER AGAIN. WHEN I FINALLY GOT A HOLD OF THE DOCTOR, SHE RECOMMENDED I INCREASE MY SLEEPING MEDICATION. HOWEVER, I WAS AT THE HIGHEST DOSE, WHICH SHE WOULD HAVE KNOWN IF SHE LOOKED AT MY CHART. SHE SAID SHE WOULD CONTACT THE "RXING" DOCTOR. SHE NEVER DID. I CALLED HER DAILY FOR 5 DAYS AND SHE DIDN'T GET BACK TO ME FOR 5 DAYS. SHE, DR. (B)(6) DIDN'T SEE HOW BIG MY PROBLEMS WERE. I FINALLY GOT AN EMAIL ADDRESS FOR THE SECRETARY, BUT ONLY AFTER NUMEROUS CALLS. AS A MEDICAL PROFESSIONAL, I HAD HIGH HOPES FOR THIS TREATMENT. I NEVER DREAMED I WOULD GET TREATED SO HORRIBLY. AFTER VERY LITTLE SLEEP FOR A WEEK, I HAD HORRIBLE ANGER OUTBURSTS, HORRIBLE CRUEL THOUGHTS ABOUT PEOPLE I LOVE AND AWFUL HEADACHES. I STILL HAVE SO MANY PROBLEMS. I STILL CAN'T SLEEP WITHOUT MEDICATION. I CAN'T READ LIKE I USED TO. I USED TO LOVE TO READ AND NOW, IT IS ALMOST IMPOSSIBLE. I SO WISH I HAD KNOWN THIS COULD HAPPEN. AND I WISH MY DOCTOR WAS MORE AVAILABLE. I DIDN'T KNOW WHAT WAS HAPPENING AND THOUGHT I WOULD KILL MYSELF. SHE DIDN'T SEEM TO CARE. AND THEIR ANSWERING SERVICE PEOPLE IN INDIA CONTINUED TO LIE WHEN I CALLED. THE MACHINE WAS BRAINSWAY. I HOPE OTHERS DON'T HAVE TO GO THROUGH THIS. MY FRIEND FINALLY FIGURED OUT THAT MY BRAIN THOUGHT IT WAS STILL GOING ON. THROUGH ENERGY WORK, SHE WAS ABLE TO TURN IT OFF. I STILL HAVE LOTS OF PROBLEMS UNFORTUNATELY. NO ONE SEEMS TO CARE OR HAVE ANSWERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082815 BRAINSWAY TMS MACHINE TRANSCRANIAL MAGNETIC STIMULATOR OBP BRAINSWAY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R 6.5 MG CR | AMBIEN 50 MCG | BACLOFEN PRN| BERBERINE| LEVOTHYROXINE QD 25 MCG | LIOTHYRONINE 1 BID 15 MCG QD | LIPOSOMAL C| MACA| MAGNESIUM| NAC| POTASSIUM| SERENAGEN| ZINC