BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAINSWAY TMS

    MDR report key: 15147009 · Received August 2, 2022

    Report

    Report Number
    MW5111205
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 29, 2022
    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 WAS DOING TRANSCRANIAL MAGNETIC THERAPY, TMS. I STARTED (B)(6) 2022. IT HAS BEEN A HORRIFIC EXPERIENCE. I DID 15 TREATMENTS. THE FIRST PROBLEM WAS WITH THE ACTUAL DOCTOR OFFICE. DR. (B)(6) WAS MY ASSIGNED PSYCHIATRIST. SHE INTERVIEWED ME WITH 3 MEDICAL STUDENTS. I FILLED OUT NUMEROUS FORMS BEFORE MY APPOINTMENT. SCHEDULED MY APPOINTMENT FOR FIRST TREATMENT ON (B)(6) 2022. IT DIDN'T GO WELL BECAUSE IT WAS TOO COLD FOR ME. THE TECH WOULDN'T GET MY COAT OUT OF MY CAR. HAD TO STOP; 2ND, 3RD, 4TH TREATMENTS WERE OKAY. OFFICE RAN LATE. DIDN'T HAVE A LIST OF MY SCHEDULED APPS. LOTS OF OTHER OFFICE PROBLEMS. HAD TROUBLE SLEEPING. REPORTED TO TECH. DIDN'T SEEM CONCERNED. COULDN'T TALK TO DR. CONTINUED TO HAVE PROBLEMS SLEEPING. TRIED TO TALK TO DR. (B)(6). SHE WAS UNAVAILABLE. CONTINUED TO REPORT PROBLEMS AND CANCELED TREATMENT SEVERAL TIMES. STARTED HAVING REAL PROBLEMS (B)(6) 2022. REPORTED TO FACILITY. ASKED TO TALK TO DOCTOR. NOT AVAILABLE. DAILY UNTIL (B)(6) 2022, TRIED TO GET A HOLD OF THE DOCTOR. ON (B)(6) 2022 CALLED 5 TIMES TRYING TO GET A HOLD OF THE DOCTOR. WAS FEELING SUICIDAL. LET STAFF KNOW. TALKED TO CALL CENTER IN INDIA AND THEY HUNG UP ON ME TWICE. ONE PERSON LIED AND SAID HE WAS THE OFFICE MANAGER. HE WASN'T. FINALLY GOT A HOLD OF THE OFFICE AND THE DOCTOR GOT ON THE PHONE. HAD TO WAIT FOR A CALL BACK THOUGH. SHE BLEW ME OFF BASICALLY. SAID TO TAKE A BREAK; I HAD ALREADY STOPPED. SHE WAS SUPPOSED TO CONTACT THE DOCTOR WHO PRESCRIBED MY SLEEP MEDS. SHE DIDN'T, SHE HAD PROMISED EARLIER TO GET A HOLD OF HIM BECAUSE SHE WANTED ME TO HAVE MY SLEEP MED INCREASED, EVEN THOUGH SHE SHOULD HAVE LOOKED AT MY CHART AND SEEN I WAS ON THE HIGHEST DOSE ALREADY. STILL HAVE PROBLEMS DUE TO THE TREATMENT. NO ONE IS WILLING TO HELP AT (B)(6). I CALLED TO LET THEM KNOW THAT I HAVE PROBLEMS. THEY CAN TAKE A REPORT, A SECRETARY TYPE PERSON, NOT A MEDICAL PROFESSIONAL. THEY WON'T CONTACT ME ABOUT THE PROBLEMS. THEY ONLY TAKE THE NOTES TAKEN AND THEN TALK TO THE PROVIDER! SAID THEY DON'T HAVE MEDICAL PROFESSIONALS ON STAFF. AGAIN, NO ONE TO TALK TO SO I CAN GET HELP. SO FRUSTRATING TO STILL HAVE SLEEP ISSUES DEPRESSION IS WORSE! TINNITUS IS MUCH WORSE. HAVING RAGE LIKE NEVER BEFORE. CAN'T EXPLAIN WHY THIS IS HAPPENING. MEDICAL ASSISTANT TO DR.(B)(6) CALLED AND WANTED TO TALK. SHE WOULDN'T LET ME GET OFF THE PHONE EVEN THOUGH I TOLD HER MULTIPLE TIMES WHAT AN AWFUL EXPERIENCE IT WAS FOR ME. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 18-DEC-2023, FOR MW5111205. CORRECTING DEVICE AND MANUFACTURER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161751 BRAINSWAY TMS TRANSCRANIAL MAGNETIC STIMULATOR OBP BRAINSWAY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| S AMBIEN 12.5 MG | LEVOTHYROXINE 25 MCG| LIOTHYRONINE 35 MCG BID | LIPOSOMAL C | MAGNESIUM| POTASSIUM NAC