BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE 4000

    MDR report key: 17964226 · Received October 19, 2023

    Report

    Report Number
    9615058-2023-00026
    Event Type
    Death
    Date Received
    October 19, 2023
    Date of Event
    September 19, 2023
    Report Date
    November 16, 2023
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO MALFUNCTION DETECTED. NO NEW RISK HAS BEEN RECOGNIZED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE CASE IS STILL UNDER INVESTIGATION. ACCORDING TO THE SITE, THE PATIENT'S CAUSE OF DEATH WAS HIS EXTENSIVE CARDIAC HISTORY AND THAT THE EVENT IS JUST COINCIDENTAL.

    Additional Manufacturer Narrative · 0

    NO MALFUNCTION DETECTED. NO NEW RISK HAS BEEN RECOGNIZED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. OUR ASSESSMENT IS THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. ACCORDING TO THE SITE, THE PATIENT'S CAUSE OF DEATH WAS HIS EXTENSIVE CARDIAC HISTORY AND THAT THE EVENT IS JUST COINCIDENTAL.

    Description of Event or Problem · 0

    PATIENT WAS TREATED FOR ESSENTIAL TREMOR ON (B)(6) AND NO SIDE EFFECTS WERE OBSERVED AFTER THE PROCEDURE. ON (B)(6) THE PATIENT PASSED AWAY IN HIS SLEEP.

    Description of Event or Problem · 0

    PATIENT WAS TREATED FOR ESSENTIAL TREMOR ON (B)(6) AND NO SIDE EFFECTS WERE OBSERVED AFTER THE PROCEDURE. ON (B)(6) THE PATIENT PASSED AWAY IN HIS SLEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738645 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death