BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR TMS

    MDR report key: 11258480 · Received February 1, 2021

    Report

    Report Number
    MW5099098
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    September 11, 2020
    Report Date
    January 28, 2021
    Manufacturer
    NEURONETICS INC.
    Product Code
    OBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TMS WAS PERFORMED BY A DOCTOR WHO APPARENTLY WAS NOT LICENSED TO ADMINISTER NEUROSTAR TMS. I EXPLAINED PRIOR TO TREATMENT MAPPING THAT I HAD A BRAIN INJURY. DOCTOR ALSO KNEW I WAS NOT TAKING AN ANTIDEPRESSANT BUT CALLED ONE IN AND SAID NOT TO PICK IT UP AT PHARMACY. AFTER 4 OR 5, TREATMENTS I BEGAN HAVING SEIZURES AND WAS SUICIDAL, YET DOCTOR BELITTLED ME AND WOULD NOT REPORT TO NEUROSTAR OR STOP TREATMENTS. I WAS SUICIDAL. I HAVE MULTIPLE TRIPS TO HOSPITALS. SEVERE MUSCLE AND JOINT PAIN, MIGRAINES, PSYCHOSIS AND MAJOR ANXIETY. NO ONE WAS LISTENING. MY NEUROLOGIST WOULD NOT DO AN EEG BECAUSE I HAD TMS. DOCTORS KNOW NOTHING AND IM IN (B)(6). PLEASE HELP I'M SEEKING ATTORNEYS AS I CANNOT WORK OR TAKE CARE OF MYSELF. STOP TMS. MORE CARE IS NEEDED DURING AND AFTER TREATMENTS. PEOPLE ARE DYING FROM SUICIDE NUMBER MENTAL HEALTH MATTERS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155913 NEUROSTAR TMS TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R| S