BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 22902650 · Received August 27, 2025

    Report

    Report Number
    9615058-2025-00036
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    November 30, 2025
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMBALANCE/FALLING IS A KNOWN SIDE EFFECT LISTED IN THE INFORMATION FOR PRESCRIBERS. THE INVESTIGATION OF THIS INCIDENT HAS NOT YET BEEN COMPLETED AND THIS REPORT WILL BE UPDATED FOLLOWING A FINALIZED INVESTIGATION. NOTE: INSIGHTEC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE.

    Additional Manufacturer Narrative · 0

    IMBALANCE/FALLING IS A KNOWN SIDE EFFECT LISTED IN THE INFORMATION FOR PRESCRIBERS. NOTE: INSIGHTEC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. INSIGHTEC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    FOLLOWING FOCUSED ULTRASOUND TREATMENT FOR ESSENTIAL TREMOR (SECOND SIDE TREATMENT), THE PATIENT FELL AND WAS TAKEN TO THE EMERGENCY ROOM.

    Description of Event or Problem · 0

    FOLLOWING FOCUSED ULTRASOUND TREATMENT FOR ESSENTIAL TREMOR (SECOND SIDE TREATMENT), THE PATIENT FELL AND WAS TAKEN TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380496 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability