BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE 4000

    MDR report key: 17936903 · Received October 15, 2023

    Report

    Report Number
    9615058-2023-00024
    Event Type
    Death
    Date Received
    October 15, 2023
    Date of Event
    June 18, 2023
    Report Date
    October 26, 2023
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO MALFUNCTION WAS DETECTED KNOWN RISK OF THE DEVICE. NO NEW RISK HAS BEEN RECOGNIZED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE EVENT IS RELATED TO THE PATIENT'S MEDICAL CONDITION AND IT IS CONSIDERED AN OFF-LABEL TREATMENT.

    Additional Manufacturer Narrative · 0

    THE CASE IS STILL UNDER INVESTIGATION. PER THE CURRENT DETAILS, THIS APPEARS TO BE AN OFF LABEL TREATMENT.

    Description of Event or Problem · 0

    PATIENT UNDERWENT ET TREATMENT FOR THEIR RIGHT HAND ON (B)(6) WITH NO REPORTED SIDE EFFECTS. ON (B)(6) PATIENT WAS FOUND IN HIS APARTMENT HAVING DEVELOPED INTRACEREBRAL HEMORRHAGE. ON (B)(6) THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    PATIENT UNDERWENT ET TREATMENT FOR THEIR RIGHT HAND ON (B)(6) 2023 WITH NO REPORTED SIDE EFFECTS. ON (B)(6) 2023 PATIENT WAS FOUND IN HIS APARTMENT HAVING DEVELOPED INTRACEREBRAL HEMORRHAGE. ON (B)(6) 2023 THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969802 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Death