BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19277105 · Received May 9, 2024

    Report

    Report Number
    9615058-2024-00018
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 9, 2024
    Report Date
    July 4, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461021
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT REPORTED DESCRIBES AN ANTICIPATED SIDE EFFECT ACCORDING TO THE INSIGHTEC IFU.THE INVESTIGATION FOR THIS EVENT IS STILL ONGOING. IF NEW DETAILS ARE RECIEVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE SYSTEM PERFORMANCE WAS FOUND TO BE ACCORDING TO SPEC AND AS EXPECTED. NO NEW RISK HAS BEEN RECOGNIZED. THE ADVERSE EVENT REPORTED DESCRIBES AN ANTICIPATED SIDE EFFECT ACCORDING TO THE INSIGHTEC IFU.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. FOLLOWING THE TREATMENT, THE PATIENT EXPERIENCED PARESIS.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT ON THE LEFT SIDE TO TREAT ESSENTIAL TREMOR ON THE RIGHT HAND. IMMEDIATELY FOLLOWING THE TREATMENT, THE PATIENT EXPERIENCED PARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469781 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability