BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE 4000

    MDR report key: 15468883 · Received September 22, 2022

    Report

    Report Number
    9615085-2022-00025
    Event Type
    Death
    Date Received
    September 22, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 22, 2022
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS DETECTED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE SYSTEM PERFORMANCE WAS FOUND TO BE AS EXPECTED. NO NEW RISKS WERE IDENTIFIED. THE INTERNAL INVESTIGATION ANALYSIS COULD NOT FIND ANY RELATION BETWEEN THE TREATMENT AND PATIENT'S HEART ATTACK. THIS IS IN LINE WITH THE NEUROSURGEON'S VIEW WHO ADVISED IT SEEMS UNLIKELY THAT HIS HEART ATTACK WAS DIRECTLY RELATED TO TREATMENT.

    Description of Event or Problem · 0

    PATIENT WAS TREATED ON (B)(6) 2022, FOR ESSENTIAL TREMOR (ET). THE PATIENT LEFT WITH TREMOR RELIEF AND PARESTHESIA IN HIS RIGHT LEG THAT HE MENTIONED WAS STARTING TO RESOLVE. POST OP MR IMAGES THAT WERE TAKEN IMMEDIATELY AFTER THE TREATMENT SHOWED A SMALL, FOCAL LESION WITH NO VISIBLE NECROTIC CORE AND LITTLE EDEMA. ON (B)(6), PATIENT COMPLAINED OF CHEST PAIN WHICH RESOLVED WITH ANTACIDS. THIS WAS SUSPECTED AS HEARTBURN. ON (B)(6) (11 DAYS AFTER TREATMENT), PATIENT DEVELOPED CHEST PAIN AGAIN, AND WAS ADMITTED TO THE HOSPITAL WHERE HE WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION AND TREATMENT WAS ATTEMPTED IN THE CATHLAB. HE DIED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751803 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| D