BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE NEURO FOCUSED ULTRASOUND

    MDR report key: 10605698 · Received September 29, 2020

    Report

    Report Number
    MW5096937
    Event Type
    Death
    Date Received
    September 29, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 25, 2020
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    POH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT INITIAL PRESENTED WITH RIGHT FACIAL PAIN WHO WAS DIAGNOSED IN 2013 WITH STAGE 4B SQUAMOUS CELL CARCINOMA OF THE RIGHT TONSIL/TONGUE. THIS PT ENROLLED IN A CLINICAL TRIAL ((B)(6)) ON (B)(6) 2020 FOR HEAD AND NECK CANCER PAIN AND WAS SUBSEQUENTLY TREATED WITH FOCUSED ULTRASOUND ON (B)(6) 2020 WITHOUT ANY UNEXPECTED ISSUES/ADVERSE EVENTS, ON (B)(6) 2020 THE PATIENT WAS ADMITTED TO AN OUTSIDE HEALTHCARE FACILITY WITH SEVERE E.COLI SEPSIS IN THE SETTING OF LOBAR PNEUMONIA. THE PATIENT EXPIRED THE FOLLOWING MORNING ON (B)(6) 2020, THE PL DEEMED THIS EVENT UNRELATED TO THE FOCUSED ULTRASOUND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065527 EXABLATE NEURO FOCUSED ULTRASOUND MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC, LTD. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H