BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 14450956 · Received May 20, 2022

    Report

    Report Number
    9615058-2022-00013
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 18, 2022
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDED KNOWN SIDE EFFECTS. NO MALFUNCTION WAS DESCRIBED. NO NEW RISKS WERE RECOGNIZED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT PATIENT EXPERIENCED SLURRED SPEECH AND WEAKNESS, DURING AND AFTER ESSENTIAL TREMOR TREATMENT. SYMPTOMS WERE REPORTED AS ISCHEMIC STROKE BY THE TREATING TEAM. THIS PATIENT HAD BACKGROUND DISEASES THAT ARE RISK FACTORS FOR A STROKE. 24HR POST TREATMENT UPDATE: PATIENT IS ALMOST BACK TO BASELINE AND IS GETTING ANOTHER MRI. YET, AT THIS POINT PERMANENT DAMAGE CANNOT BE RULED OUT, THEREFORE THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268860 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability