BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN ROBOT

    MDR report key: 23495410 · Received November 6, 2025

    Report

    Report Number
    MW5178577
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    January 6, 2010
    Report Date
    November 3, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2020 I HAD A STEREOTACTIC EEG PERFORMED AT (B)(6). THE ROSA ONE BRAIN ROBOT WAS USED DURING THIS SURGERY TO PLACE 16 DEPTH ELECTRODES INTO MY BRAIN. THE LEADS WERE MISPLACED DURING THIS TEST GIVING MISINFORMATION TO THE DOCTORS. SUBSEQUENTLY WHEN MY NEUROPACE STIMULATOR WAS IMPLANTED THE LEADS WERE PLACED WRONG. ONE OF THE LEADS WAS IN MY HIPPOCAMPUS CAUSING PAIN FROM THE STIMULATION AND WAS TURNED OFF. THE OTHER LEAD WAS PLACED NEXT TO THE FORAMEN OVALE, CAUSING ME TO FEEL THE STIMULATION IN MY LEFT TEMPLE AND EYE AND CAUSING FACIAL PAIN. THE PAIN WAS VERY INTENSE, AND I HAVE LASTING EYE PAIN, ISSUES WITH MY LEFT EYE AND EXTREME MEMORY ISSUES. AFTER 4 YEARS OF ARGUING THIS INFORMATION WAS GIVEN TO ME AND SURGERY WAS PERFORMED IN 2024 TO REMOVE AND REIMPLANT THE DEVICE AND LEADS DUE TO THEM BEING PLACED WRONG. DURING THIS TIME, I HAD MORE INTENSE AND MORE FREQUENT SEIZURES AS WELL I HAVE FREQUENT MIGRAINE HEADACHES FROM ALL THE INCISIONS AND SCARE TISSUE AND EXTREME ANXIETY OVER WHETHER I HAVE ONCE AGAIN FELT THE STIMULATION OR NOT. PT CODES: 4467; 1994; 1958; 4406; 1880; 2060; 2328; 1924. DEVICE CODES: 1508, 1158, 3023. REF REPORT: MW5178578.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924654 ROSA ONE BRAIN ROBOT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTECH SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other| S| L| H APTIOM.| LAMITCAL.| LORAZAPAM.| PHOSPHORUS.| RNS NEUROPACE.| VALTACO.| VITIMAN B.| VITIMAN D PHOSPHATE.