BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19219793 · Received May 1, 2024

    Report

    Report Number
    9615058-2024-00015
    Event Type
    Injury
    Date Received
    May 1, 2024
    Report Date
    May 1, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT REPORTED DESCRIBES AN ANTICIPATED SIDE EFFECT ACCORDING TO THE INSIGHTEC IFU. THIS COMPLAINT WAS RECEIVED FROM THE PATIENT THROUGH INSIGHTEC'S WEBSITE AND WAS RECEIVED WITH LIMITED DETAILS. THIS ADVERSE EVENT IS REPORTED WITH THE INFORMATION REPORTED BY THE PATIENT. NO ADDITIONAL INFORMATION COULD BE GATHERED FROM THE TREATING SITE. IF MORE INFORMATION IS GATHERED IN THE FUTURE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT TO TREAT ESSENTIAL TREMOR. FOLLOWING THE TREATMENT, THE PATIENT ALSO EXPERIENCED WEAKNESS ON THE RIGHT SIDE AND BALANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132084 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability