BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19481616 · Received June 7, 2024

    Report

    Report Number
    9615058-2024-00022
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    November 24, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461021
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT REPORTED DESCRIBES AN ANTICIPATED SIDE EFFECT ACCORDING TO THE INSIGHTEC IFU. THE INVESTIGATION FOR THIS EVENT IS STILL ONGOING. IF NEW DETAILS ARE RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE MALFUNCTION. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE TREATMENT PROCESS WAS AS EXPECTED. NO NEW RISK HAS BEEN RECOGNIZED. THE ADVERSE EVENT REPORTED DESCRIBES AN ANTICIPATED SIDE EFFECT ACCORDING TO THE INSIGHTEC IFU AND IS EXPECTED TO BE TRANSIENT.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. THE PATIENT PRESENTED WITH A BURN THE SIZE OF A NICKEL ABOUT AN INCH ABOVE THE RIGHT EAR.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. THE PATIENT PRESENTED WITH A BURN THE SIZE OF A NICKEL ABOUT AN INCH ABOVE THE RIGHT EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151234 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability