BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR TMS THERAPY

    MDR report key: 14592588 · Received June 3, 2022

    Report

    Report Number
    3004824012-2022-00001
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    June 1, 2018
    Report Date
    June 2, 2022
    Manufacturer
    NEURONETICS, INC.
    Product Code
    OBP
    UDI-DI
    00869378000117
    PMA / PMN Number
    K161519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEURONETICS WAS ABLE TO SPEAK WITH THE PATIENT AND THE TMS PROVIDER FOR ADDITIONAL INFORMATION. PATIENT RECEIVED A MAPPING SESSION AND 3 TREATMENTS ONLY WITH NEUROSTAR TMS. THE TREATING PHYSICIAN CONFIRMED THAT THE "DARKENED SKIN" WAS DUE TO MARKING THE PATIENT'S HEAD WITH A MARKER. HE ALSO DID NOT THINK THE PATIENT'S OTHER SYMPTOMS WERE RELATED TO TMS SINCE HE ONLY HAD 3 TREATMENTS AND THEY NEVER GOT ABOVE 50% OF 0.81% OF THE MOTOR THRESHOLD. THE PHYSICIAN HAD RECOMMENDED THE PATIENT GET AN MRI BUT THE PATIENT HAD NOT FOLLOWED THROUGH.

    Description of Event or Problem · 0

    NEURONETICS, INC. RECEIVED A PATIENT SELF-REPORTED MEDWATCH FORM (MW5108910) FROM FDA ON 05/03/2022. THE PATIENT ALLEGES LONG-TERM SIDE EFFECTS FROM THREE (3) TMS TREATMENTS HE HAD IN 2018. THE PATIENT REPORTED PROLONGED HEADACHE AND SKIN DISCOLORATION AT THE TREATMENT SITE FOLLOWING TREATMENT. HE ALSO REPORTED TINNITUS AND LIGHT SENSITIVITY THAT HAS PERSISTED FOR ALMOST FOUR (YEARS). THE PATIENT ACKNOWLEDGED THAT HE DID NOT USE HEARING PROTECTION BUT USED PERSONAL EAR BUDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834074 NEUROSTAR TMS THERAPY TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS, INC. NeuroStar 3.0 US 00869378000117

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability MEDICAL MARIJUANA.