BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 16483732 · Received March 6, 2023

    Report

    Report Number
    9615058-2023-00007
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 5, 2023
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDES KNOWN PROCEDURE RELATED RISK FOR TREMOR DOMINANT PARKINSON'S DISEASE TREATMENT. NO NEW RISKS WERE IDENTIFIED. NO DEVICE MALFUNCTION WAS DETECTED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE.

    Description of Event or Problem · 0

    DEEP VENOUS THROMBOSIS (DVT) IN LEFT LOWER EXTREMITY FOLLOWING TREMOR DOMINANT PARKINSON'S DISEASE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549251 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| S