BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 12030238 · Received June 20, 2021

    Report

    Report Number
    9615058-2021-00016
    Event Type
    Injury
    Date Received
    June 20, 2021
    Date of Event
    October 20, 2020
    Report Date
    August 23, 2023
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461021
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KNOWN RISK OF THE DEVICE. NO DEVICE MALFUNCTION. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THIS IS AN ADDITIONAL, FOLLOW-UP COMPLAINT WE RECEIVED FROM THE PATIENT WHICH PROVIDED US WITH FURTHER DETAILS (VIA THE COMPANY WEBSITE ON JUNE 06,2023) AND ENABLED US TO INVESTIGATE THIS CASE. SINCE THIS COMPLAINT WAS RECEIVED DIRECTLY FROM THE PATIENT, POST TREATMENT DATA IS NOT AVAILABLE.

    Description of Event or Problem · 0

    PATIENT REPORTED GAIT DISTURBANCE FOLLOWING ESSENTIAL TREMOR TREATMENT. THE PATIENT FIRST COMPLAINED VIA FACEBOOK ON FEBRUARY 02, 2021. WE RECIEVED AN ADDITIONAL COMPLAINT RECENTLY THROUGH OUR COMPANY WEBSITE ON JUNE 06,2023.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THE COMPANY DOES NOT HAVE ENOUGH DETAILS TO INVESTIGATE. THE COMPLAINANT RECEIVED A POST BACK THAT SHE SHOULD CONTACT HER TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Description of Event or Problem · 1

    IN THE COMPANY (B)(6) PAGE, PATIENT MENTIONED THAT AFTER THE PROCEDURE SHE IS FALLING A LOT (GAIT DISTURBANCES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927126 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability