BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMS TRANSMAGNETIC CRANIAL STIMULATION DEVICE NEUROSTAR

    MDR report key: 14084843 · Received April 11, 2022

    Report

    Report Number
    MW5108910
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    June 1, 2018
    Report Date
    April 7, 2022
    Manufacturer
    NEURONETICS INC.
    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

    DR (B)(6) TOLD ME NEUROSTAR TMS (TRANSMAGNETIC CRANIAL STIMULATION) WAS SIDE EFFECT FREE OTHER THAN POSSIBLE HEADACHE THE FIRST 3 TREATMENTS. BEFORE THE "TREATMENT" I WAS TOLD I COULD LISTEN TO MY EARBUDS IF I FELT LIKE IT BUT JUST TO TRY NOT TO FALL ASLEEP. THE TECH SAID THEY'RE INDUCING A SEIZURE IN ME FIRST THING TO GET MY "BASELINE". THIS SHOULD HAVE BEEN MY WARNING SIGN BUT DR (B)(6) SAID THERE'S A 67% CHANCE I'LL NEVER NEED PSYCHIATRY AGAIN. AFTER THE TREATMENT WHICH WAS SIMILAR TO A JACKHAMMER OPERATED 1/4" FROM MY HEAD, I IMMEDIATELY DEVELOPED THE WORST HEADACHE OF MY LIFE WHICH WOULD LAST WEEKS. THEY CONVINCED ME THAT HORRIBLE SIDE EFFECTS WERE NORMAL AND I ENDURED 3 "TREATMENTS." MY SKIN DARKENED AT THE SITE OF THE TMS PROBE. I DEVELOPED RINGING MY EARS WHICH NEVER WAS AN ISSUE BEFORE. LIGHT AND SOUND BECAME PAINFUL PERMANENTLY. I SPENT 2 WEEKS SLEEPING WITH A TOWEL OVER MY EYES. I'M WRITING THIS ALMOST 4 YEARS LATER AND I HAVE NOT IMPROVED. DR (B)(6) GASLIGHTED ME AND CLAIMED "EARPLUGS WERE OFFERED" ALSO THAT IT'S IMPOSSIBLE HIS "SAFE TMS MACHINE" CAUSED THIS. HE CLAIMED NOBODY ELSE HAD EVER HAD ANY SIDE EFFECT FROM TMS. I'VE HAD MENTAL EFFECTS THAT IMPACT MY ABILITY TO WORK AND SOCIALIZE. I'VE HAD TO CHANGE THE TYPE OF WORK I DO AND LIMIT SOCIAL EVENTS INVOLVING LIGHT OR NOISE. WATCHING A MOVIE MY TMS-PTSD IS TRIGGERED WITH REVERBERATING SOUNDS LIKE HELICOPTER NOISES. BELIEVING THIS PSYCHIATRIST AND DOING TMS WAS THE WORST DECISION I'VE EVER MADE. RESEARCHING TMS I DISCOVERED THAT MANY PEOPLE HAVE HAD THESE SAME TRAUMATIC BRAIN INJURY SYMPTOMS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900480 TMS TRANSMAGNETIC CRANIAL STIMULATION DEVICE NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Disability