BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 19228608 · Received May 2, 2024

    Report

    Report Number
    9615058-2024-00016
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    March 8, 2024
    Report Date
    August 8, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461091
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    NO IRREGULARITIES WITH DEVICE OR MR OPERATION. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THE TREATMENT PROCESS WAS AS EXPECTED. NO NEW RISK HAS BEEN RECOGNIZED. THE SKIN BLISTERS ARE MOST LIKELY DUE TO SUPERFICIAL HEAD INJURIES FROM HEAD SHAVING AND EXPOSURE TO COLD WATER INSIDE THE TRANSDUCER, AND PRESSURE FROM THE MEMBRANE ON THE HEAD. THESE BLISTERS ARE EXPECTED TO BE TRANSIENT. THE BALANCE ISSUES WERE REPORTED BY THE PATIENT THROUGH THE COMPANY WEBSITE WITH LIMITED INFORMATION.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT FOR ESSENTIAL TREMOR. THE PATIENT DEVELOPED BURN SPOTS ON THEIR RIGHT SCALP ABOVE THEIR EAR AND TOWARDS THE FRONT.

    Description of Event or Problem · 0

    PATIENT UNDERWENT FOCUSED ULTRASOUND TREATMENT FOR ESSENTIAL TREMOR. THE PATIENT DEVELOPED BLISTERS AT VARIOUS LOCATIONS AROUND THEIR SCALP. ON (B)(6) 2024, THE PATIENT SENT A COMPLAINT VIA THE INSIGHTEC WEBSITE AND UPDATED THAT THEY ARE ALSO EXPERIENCING BALANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438357 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| H