BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE 4000

    MDR report key: 11761853 · Received May 3, 2021

    Report

    Report Number
    9615058-2021-00010
    Event Type
    Death
    Date Received
    May 3, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 3, 2021
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETROSPECTIVE ANALYSIS HAS NOT INDICATED ANY TECHNICAL FAILURES OR ERRONEOUS OPERATION OF THE SYSTEM. THE TREATMENT WAS PLANNED AND EXECUTED IN ACCORDANCE WITH TREATMENT GUIDELINES AND LABELING. IT APPEARS THAT TREATMENT PARAMETERS WERE WITHIN NORMAL RANGE FOR THIS TYPE OF TREATMENT. ACCORDING TO THE TREATING SITE TEAM, THE DEATH IS MOST LIKELY NOT RELATED TO THE TREATMENT BUT SINCE AUTOPSY WILL NOT BE CONDUCTED (PER FAMILY CHOICE), THE CERTAINTY IS LIMITED. ACCORDING TO THIS TREATMENT REVIEW, WE SEE NO EVIDENCE OF FAILURE, MALFUNCTION, IMPROPER OR INADEQUATE DESIGN, MANUFACTURE, LABELING OR USER ERROR RESULTING IN THE ADVERSE EVENT.

    Description of Event or Problem · 1

    ACCORDING TO INFORMATION FROM THE TREATING PHYSICIANS: PATIENT, (B)(6) YEARS OLD PREVIOUSLY DIAGNOSED WITH COPD UNDERWENT ESSENTIAL TREMOR TREATMENT. THE TREATMENT ENDED SUCCESSFULLY WITH GOOD TREMOR CONTROL AND NO ADVERSE EVENTS REPORTED POST PROCEDURE. AFTER THE TREATMENT AND AS PART OF THE ROUTINE HOSPITAL'S PROCEDURE, THE PATIENT WAS HELD FOR OBSERVATION UNTIL LATER IN THE EVENING AFTER THE PROCEDURE. HE WAS DISMISSED FROM THE HOSPITAL THAT EVENING. THE FOLLOWING DAY HE WAS FEELING WELL AND SATISFIED WITH THE TREMOR REDUCTION. IN THE EVENING, THE PATIENT UNEXPECTEDLY DIED WHILE EATING DINNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659910 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death