BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMS

    MDR report key: 16844594 · Received April 28, 2023

    Report

    Report Number
    MW5117164
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    November 16, 2022
    Report Date
    April 26, 2023
    Manufacturer
    UNK
    Product Code
    OBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    STARTED TMS, AROUND THE 8 SESSION I'M SLURRING MY SPEECH. THE DR. IT'S NOT FROM TMS. AT MY 30TH SESSION I GREW CONCERNED BECAUSE MY SPEECH WAS WORSE. AGAIN, THE DR SAID WASN'T FROM TMS. I CANCELLED THE REMAINDER OF MY TREATMENT. "12/28" HAD AN CT TO SEE IF I HAD ANY BRAIN DAMAGE. NOTHING SHOWED ON THE CT. SINCE I HAVE HAD TWO MRI'S AND A NEURO VISIT. EVERYTHING COMES BACK NORMAL. I AM STARTING SPEECH THERAPY 5/1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534288 TMS TRANSCRANIAL MAGNETIC STIMULATOR OBP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other 40MG PROZAC | 50MG AMITRIPTYLINE