BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT RC+S

    MDR report key: 17957540 · Received October 17, 2023

    Report

    Report Number
    MW5147070
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BASED ON THE PATIENT'S SELF-REPORT, HE GENERALLY FELL APPROXIMATELY 1-2 TIMES A MONTH WHILE HE WAS ON STANDARD OF CARE DBS TREATMENT. DURING THE WEEK OF (B)(6) 2023 WHILE THE PATIENT WAS IN THE DOUBLE-BLINDED TESTING PHASE, THE PATIENT AND THE STUDY INVESTIGATORS WERE BLINDED TO THE ASSIGNED TREATMENT GROUP (CONTINUOUS DBS VS ADAPTIVE DBS), THE PATIENT REPORTED HE HAD FALLEN 3 TIMES THAT WEEK. WHILE TEMPORARY WORSENING OF USUAL MOVEMENT DISORDERS SYMPTOMS RELATED TO BRAIN RECORDING AND ADAPTIVE DBS WAS ALREADY LISTED IN THE STUDY CONSENT AS A POSSIBLE RISK AND SIDE EFFECT, THE FREQUENCY OF THE OCCURRENCE WAS HIGHER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89809 SUMMIT RC+S STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male