BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR ADVANCED THERAPY

    MDR report key: 24903600 · Received April 16, 2026

    Report

    Report Number
    3004824012-2026-00014
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 16, 2026
    Manufacturer
    NEURONETICS, INC.
    Product Code
    QCI
    UDI-DI
    00869378000117
    PMA / PMN Number
    K161519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT RECEIVED 3 MDD TREATMENTS THEN HAD OCD TREATMENT ADDED. AFTER THE PATIENT'S 3RD OCD TREATMENT, THE PATIENT BEGAN TO EXPRESS MANY COMPLAINTS (LISTED TOTAL OF 63). BOTH THE PRACTICE AND THE PATIENT ATTRIBUTED THE COMPLAINTS TO HIS PRE-EXISTING TYPE OF OCD IN WHICH HE FIXATES ON THINGS HE CANNOT SEE THAT ARE HAPPENING INSIDE HIS BODY. FOR EXAMPLE, HE STARTED TO HAVE AN INTRUSIVE FEAR THAT THE TMS WAS GOING TO HURT HIS BRAIN. WHEN OFFICE MANAGER OF THE PRACTICE SPOKE WITH HIM ON THE PHONE ON (B)(6) 2026, HE WAS STILL EMPLOYED AND PARTICIPATING IN TRAVEL FOR WORK. COMPLAINT HAS NOT RESOLVED. ON (B)(6) 2026, NNI REQUESTED A STATUS FROM THE PATIENT WHO STATED THAT HE THINKS HIS COMPLAINTS ALSO REVOLVE AROUND THE MDD TREATMENT. IN ADDITION, THE PATIENT EXPERIENCED PANIC ATTACKS WHICH HE HAD NOT HAD SINCE 2014. HE HAS NOT NOTED HAVING ANY FURTHER PANIC ATTACKS. HE TOLD THE OFFICE MANAGER THAT HE WENT BACK TO THE OFFICE WHERE HE HAD RECEIVED PREVIOUS FULL COURSE OF TMS FOR MDD. ACCORDING TO THE PATIENT, HE CONTINUED WITH MDD TREATMENT AT ANOTHER PRACTICE BUT DID NOT ADD OCD.

    Description of Event or Problem · 0

    PATIENT EMAILED THE PRACTICE AND NNI DIRECTLY BUT SEPARATELY REGARDING A VERY LONG LIST OF COMPLAINTS THAT HE FELT ARE RELATED TO TMS TREATMENT. THE PATIENT LISTED A LARGE NUMBER OF ISSUES WHICH WHEN REVIEWED SHOWED A WORSENING OF OCD AND POSSIBLY MDD SYMPTOMS WHICH APPEAR TO HAVE STARTED AFTER HAVING OCD ADDED TO THE MDD TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344697 NEUROSTAR ADVANCED THERAPY TMS QCI NEURONETICS, INC. V.3.0 00869378000117

    Patients

    Seq Age Sex Outcome Treatment
    1