BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19473395 · Received June 5, 2024

    Report

    Report Number
    9615058-2024-00021
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    April 4, 2024
    Report Date
    August 14, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT REPORTED DESCRIBES ANTICIPATED SIDE EFFECTS ACCORDING TO THE INSIGHTEC IFU. THIS EVENT WAS REPORTED BY THE PATIENT THROUGH INSIGHTEC'S WEBSITE AND WAS REPORTED WITH LIMITED INFORMATION. THE INVESTIGATION FOR THIS EVENT IS STILL ONGOING AND THIS REPORT WILL BE UPDATED ONCE THE INVESTIGATION IS FINALIZED.

    Additional Manufacturer Narrative · 0

    KNOWN RISK OF THE DEVICE. NO DEVICE MALFUNCTION DETECTED. TREATMENT PARAMETERS IN LINE WITH TYPICAL RANGE. NO NEW RISK HAS BEEN RECOGNIZED. THIS EVENT WAS REPORTED BY THE PATIENT THROUGH INSIGHTEC'S WEBSITE AND WAS REPORTED WITH LIMITED INFORMATION.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. FOLLOWING THE TREATMENT, THE PATIENT EXPERIENCED WEAKENS'S AND IMBALANCE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. NO ADVERSE EVENTS WERE NOTED DURING THE TREATMENT OR IMMEDIATELY FOLLOWING TREATMENT. THE PATIENT LATER DEVELOPED RIGHT SIDED WEAKNESS AND IMBALANCE WITH GAIT ISSUES. THIS PERSISTED OVER A PERIOD OF TWO MONTHS, INITIALLY WORSENING IN SEVERITY AND THEN IMPROVING WITH TIME. THE PHYSICIAN SHARED THAT THE PATIENT HAD BEEN SHOWING IMPROVEMENT AND THEY EXPECTED THE PATIENT TO RECOVER COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9356 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Disability