BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR ADVANCED THERAPY

    MDR report key: 18438485 · Received January 3, 2024

    Report

    Report Number
    3004824012-2024-00001
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    November 29, 2023
    Report Date
    January 3, 2024
    Manufacturer
    NEURONETICS, INC.
    Product Code
    OBP
    UDI-DI
    00850005944522
    PMA / PMN Number
    K230029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PROVIDER CONTACTED NEURONETICS TO REPORT THAT THEY HAD LEARNED THAT ONE OF THEIR PAST PATIENTS HAD ATTEMPTED SUICIDE AND HAS BEEN HOSPITALIZED. THE PROVIDER WAS INFORMED OF THIS FROM THE PATIENT'S TREATING PSYCHIATRIST. THE EVENT OCCURED OVER A MONTH AFTER PATIENT HAD FINISHED HER COURSE OF TMS. PATIENT HAD REPORTEDLY EXPERIENCED A FAMILY TRAGEDY DURING HER COURSE OF TREATMENT. PER THE PROVIDER, PATIENT HAD BEEN GETTING BETTER THROUGHOUT TREATMENT BUT THIS EVENT HAD "DERAILED" THE PATIENT'S PROGRESS AND THE PROVIDER HAD DECIDED TO EXTEND HER TREATMENT COURSE AS A RESPONSE. PATIENT HAD REPORTEDLY BEEN HAVING GENERAL SUICIDAL IDEATION PRIOR TO STARTING TMS AND HER PHQ-9 SCORES INDICATED THAT SHE HAD BEEN EXPERIENCING SUICIDAL IDEATION DURING TREATMENT AS WELL. NEURONETICS HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION FROM THE PATIENT'S TREATING PSYCHIATRIST TO DETERMINE WHAT HAD LED TO THE EVENT AND IF THE PATIENT HAS HAD A PRIOR HISTORY OF SUICIDE ATTEMPTS. NEURONETICS IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT AND IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS ATTEMPTED SUICIDE OVER A MONTH AFTER FINISHING HER TMS TREATMENT COURSE AND WAS SUBSEQUENTLY HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628627 NEUROSTAR ADVANCED THERAPY TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY V3.7 00850005944522

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Life Threatening| H ALPRAZOLAM 2 MG| CLONIDINE 2 MG| FLUOXETINE 90 MG| SUBOXONE 8 MG| ZOLPIDEM 10 MG