BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR ADVANCED THERAPY

    MDR report key: 21081607 · Received January 6, 2025

    Report

    Report Number
    3004824012-2025-00001
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    November 6, 2024
    Report Date
    January 6, 2025
    Manufacturer
    NEURONETICS, INC.
    Product Code
    OBP
    UDI-DI
    00869378000117
    PMA / PMN Number
    K161519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDWATCH REPORT INCLUDED THE PATIENT NAME AND CONTACT INFORMATION ENABLING NEURONETICS TO FOLLOW UP WITH THE PATIENT AND THE PROVIDER. PATIENT'S PHQ-9 DEPRESSION SCORE IMPROVED AFTER THE 36 TREATMENTS. THE PROVIDER COULD NOT CORROBORATE ALL THE ALLEGATIONS MADE BY THE PATIENT. PATIENT RECORD INCLUDED DISCOMFORT AND NUMBNESS IN THE RIGHT FOREARM WHICH WENT AWAY. THERE IS NO EVIDENCE TO DETERMINE IF THE PATIENT'S HEALTH COMPLAINTS ARE DUE TO TMS TREATMENT OR A PROGRESSION OF OTHER MENTAL HEALTH ISSUES (SEVERE GAD, BIPOLAR II AND/OR BORDERLINE PERSONALITY DISORDER) WHICH ARE NOT CURRENTLY CLEARED FOR TMS TREATMENT.

    Description of Event or Problem · 0

    NEURONETICS RECEIVED MEDWATCH (MW) 5162644 FROM FDA VIA EMAIL ON DECEMBER 9, 2024. IN THE MW A FEMALE PATIENT ALLEGES EMOTIONAL CHANGES AFTER RECEIVING NEUROSTAR TMS TREATMENT. THESE EMOTIONAL CHANGES INCLUDE PARANOIA, ANXIETY, AND FEELING OF ANNOYANCE AND ANGER ALL THE TIME. SHE ALSO ALLEGES FEELING OF "BUGS CRAWLING ON HER SKIN", CONSTANT HEADACHES AND PAINFUL RIGHT HAND AND FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962489 NEUROSTAR ADVANCED THERAPY TRANSCRANIAL MAGNETIC STIMULATION OBP NEURONETICS, INC. NEUROSTAR 3.0 NA 00869378000117

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other AUVELITY| B12| BENADRYL| CYMBALTA| IRON| METFORMIN| TOPROL XL| TYLENOL