BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19826730 · Received July 25, 2024

    Report

    Report Number
    9615058-2024-00024
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 25, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KNOWN RISK OF THE DEVICE AND NO NEW RISK HAS BEEN RECOGNIZED. NO DEVICE MALFUNCTION DETECTED. TREATMENT PARAMETERS IN LINE WITH TYPICAL RANGE. THE PATIENT'S CONDITION HAS BEEN IMPROVING. THESE SIDE EFFECTS MAY BE RELATED TO EDEMA THAT EVOLVED INTO THE INTERNAL CAPSULE AND IS A KNOWN RISK FOLLOWING FOCUSED ULTRASOUND TREATMENT. THIS EDEMA IS TYPICALLY TRANSIENT.ACCORDINGLY,THE PATIENT'S PHYSICIAN BELIEVES THAT THIS SIDE EFFECT WILL ALSO BE TRANSIENT.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT ON THE LEFT SIDE TO TREAT ESSENTIAL TREMOR ON THE RIGHT HAND. NO ADVERSE EVENTS WERE NOTED DURING THE TREATMENT OR IMMEDIATELY FOLLOWING TREATMENT. PATIENT DEVELOPED RIGHT-SIDED WEAKNESS WITHIN 24 HOURS OF TREATMENT THAT HAS PERSISTED AT LEAST 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357551 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability