BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 20094390 · Received August 29, 2024

    Report

    Report Number
    9615058-2024-00026
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 10, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KNOWN RISK OF THE DEVICE. THE INVESTIGATION OF THIS INCIDENT HAS NOT YET BEEN COMPLETED AND THIS REPORT WILL BE UPDATED FOLLOWING A FINALIZED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    KNOWN RISK OF THE DEVICE. NO NEW RISK HAS BEEN RECOGNIZED. NO DEVICE MALFUNCTION DETECTED. TREATMENT PARAMETERS IN LINE WITH TYPICAL RANGE. HEMIPARESIS,DYSMETRIA, AND ATAXIA ARE KNOWN SIDE EFFECTS LISTED IN THE INFORMATION FOR PRESCRIBERS. THESE SIDE EFFECTS MAY BE RELATED TO EDEMA AND HEATING THAT EVOLVED INTO THE INTERNAL CAPSULE AND IS A KNOWN RISK FOLLOWING FOCUSED ULTRASOUND TREATMENT.

    Description of Event or Problem · 0

    FOLLOWING FOCUSED ULTRASOUND TREATMENT ON THE LEFT SIDE FOR RIGHT SIDE ESSENTIAL TREMOR, PATIENT EXPERIENCED ATAXIA.

    Description of Event or Problem · 0

    IMMEDIATELY FOLLOWING TREATMENT WITH FOCUSED ULTRASOUND ON THE LEFT SIDE FOR RIGHT SIDE ESSENTIAL TREMOR, PATIENT EXPERIENCED HEMIPARESIS, SEVERE DYSMETRIA, AND ATAXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231861 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability