BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR ADVANCED THERAPY

    MDR report key: 16035931 · Received December 22, 2022

    Report

    Report Number
    3004824012-2022-00025
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 17, 2022
    Report Date
    December 22, 2022
    Manufacturer
    NEURONETICS, INC.
    Product Code
    OBP
    UDI-DI
    00850005944522
    PMA / PMN Number
    K201158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INCLUDED A REVIEW OF THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS. THE PATIENT WAS DIAGNOSED WITH ASPERGER'S SYNDROME WHICH MAY HAVE LOWERED HIS SEIZURE THRESHOLD. SEIZURE DISORDERS AND EPILEPSY ARE FREQUENTLY REPORTED COMORBIDITIES IN INDIVIDUALS WITH AUTISM SPECTRUM DISORDER WHICH INCLUDES THE SIGNS AND SYMPTOMS THAT WERE ONCE PART OF AN ASPERGER'S DIAGNOSIS. ADDITIONALLY, TWO OF THE MEDICATIONS THE PATIENT WAS TAKING (CLOMID AND AMPHETAMINE-DEXTROAMPHETAMINE) COULD ALSO POTENTIALLY LOWER HIS SEIZURE THRESHOLD.

    Description of Event or Problem · 0

    NEURONETICS, INC. RECEIVED A CALL FROM A COMPANY REPRESENTATIVE THAT ONE OF HIS ACCOUNTS HAD A PATIENT WHO HAD A SEIZURE DURING HIS 10TH TMS TREATMENT SESSION. THE SEIZURE LASTED ONLY 2-3 MINUTES BUT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND HAD A CT SCAN WHICH WAS NORMAL. THE PATIENT WAS DISCHARGED THE SAME DAY AND HAS BEEN DOING WELL WITH NO VISIBLE LASTING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2917121 NEUROSTAR ADVANCED THERAPY TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS, INC. NS 3.7 00850005944522

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other AMPHETAMINE-DEXTROAMPHETAMINE 10MG BID (HOLDING)| ANASTROZOLE 1MG| ARMOUR THYROID 90MG IN AM| CLOMID 50MG 1/2 TABLET ONCE WEEKLY| LISINOPRIL 40MG| VERAPAMIL 40MG