BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCRANIAL MAGNETIC STIMULATION DEVICE

    MDR report key: 17712156 · Received September 7, 2023

    Report

    Report Number
    MW5145389
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    March 14, 2022
    Report Date
    September 3, 2023
    Manufacturer
    UNK
    Product Code
    OBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS RECEIVING TRANSCRANIAL MAGNETIC STIMULATION (TMS). I WORE EARPLUGS TO PROTECT MY EARS. DURING WHAT I BELIEVE WAS MY THIRD SESSION, I HEARD A LOUD NOISE INSIDE MY HEAD. AFTER THE SESSION ENDED, I KEPT HEARING NOISE IN BOTH EARS. I CHOSE TO DISCONTINUE TMS OUT OF CONCERN FOR MY HEARING. I HAD NEVER HAD ANY HEARING PROBLEMS BEFORE TMS. AFTER SEVERAL DAYS, THE HEARING IN MY RIGHT EAR RETURNED TO NORMAL, BUT THE TINNITUS IN MY LEFT EAR HAS NEVER GONE AWAY. IT'S A RINGING SOUND THAT VARIES IN INTENSITY AND PITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118615 TRANSCRANIAL MAGNETIC STIMULATION DEVICE TRANSCRANIAL MAGNETIC STIMULATOR OBP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Disability