BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMS

    MDR report key: 19560756 · Received June 17, 2024

    Report

    Report Number
    MW5156387
    Event Type
    Injury
    Date Received
    June 17, 2024
    Report Date
    June 13, 2024
    Manufacturer
    UNKNOWN
    Product Code
    OKP
    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

    HAD TMS (TRANSCRANIAL MAGNETIC STIMULATION) FOR EVERY DAY FOR 45 DAYS. CAUSE CONTINUING POUNDING IN MY HEAD JUST LIKE THE TMS HELMET IS STILL ON MY HEAD. CAUSED WEAKNESS AND MOBILITY PROBLEMS. CAUSED TINNITUS. CAUSED WEAK JOINTS. CAUSED TINGLING AND NUMBNESS. CAUSED TEETH GRINDING. CAUSED PAIN BEHIND MY LEFT EYE. CAUSED HEADACHES ON TOP AND SLIGHTLY LEFT ON MY HEAD. CAUSED MY LEFT LEG TO GIVE IN AND I WOULD FALL TO THE GROUND. LEG WAS SO WEAK, I HAD TO CRAWL ONTO THE GROUND TRYING TO GET OUT OF MY CAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512865 TMS TRANSCRANIAL MAGNETIC STIMULATOR FOR THE TREATMENT OF MIGRAINE HEADACHE OKP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability GABAPENTIN. | LAMOTRIGINE. | MAXALT.| PEPTO BISMOL.| QUETIAPINE. | TENS UNIT.| XANAX.