BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONALLEVE MR-HIFU

    MDR report key: 23178980 · Received September 30, 2025

    Report

    Report Number
    3012604011-2025-00001
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    December 26, 2024
    Report Date
    September 29, 2025
    Manufacturer
    PROFOUND MEDICAL INC.
    Product Code
    NRZ
    PMA / PMN Number
    H190003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS INCONCLUSIVE WHETHER THE TENDON RUPTURE WAS A CONSEQUENCE OF THE DAMAGE CAUSED BY THE INFLAMMATORY STIMULUS FROM THE PRE-EXISTING OSTEOID OSTEOMA OR A CONSEQUENCE OF THE HIFU THERAPY OR THROUGH A COMBINATION OF BOTH FACTORS.

    Description of Event or Problem · 0

    DURING THE ANNUAL LITERATURE SEARCH DONE ON 1-SEP-2025 WAS FOUND FROM PUBLICATION (ERBER ET AL., 2024) THAT THERE HAS BEEN SERIOUS INCIDENT AFTER SONALLEVE MR-HIFU TREATMENT FOR OSTEOID OSTEOMA IN EU (GERMANY). "DURING THE STUDY ONE MAJOR ADVERSE EVENT OCCURRED IN A PATIENT WITH AN OSTEOID OSTEOMA ON THE MIDDLE PHALANX OF THE THIRD FINGER. THE PATIENT WAS PAIN FREE IMMEDIATELY AFTER TREATMENT. HOWEVER, APPROXIMATELY 6 WEEKS AFTER TREATMENT, A FLEXION DEFICIT DEVELOPED AT THE DISTAL INTERPHALANGEAL JOINT. A SUBSEQUENT MRI REVEALED A COMPLETE RUPTURE OF THE FLEXOR DIGITORUM PROFUNDUS TENDON AND SUBSEQUENTLY UNDERWENT SUCCESSFUL SURGICAL RECONSTRUCTION. THE PRE-INTERVENTIONAL MRI ALREADY SHOWED A DISTINCT CONTRAST UPTAKE OF THE TENDON AND TENDON SHEATH IN THE AREA OF THE OSTEOID OSTEOMA AS A SIGN OF PRE-EXISTING DAMAGE. THE TENDON WAS APPROXIMATELY 2 MM AWAY FROM THE OSTEOID OSTEOMA AND, DUE TO THE PATIENT'S POSITIONING, IN THE AREA OF THE ULTRASOUND BEAM." IT IS INCONCLUSIVE WHETHER THE TENDON RUPTURE WAS A CONSEQUENCE OF THE DAMAGE CAUSED BY THE INFLAMMATORY STIMULUS FROM THE PRE-EXISTING OSTEOID OSTEOMA OR A CONSEQUENCE OF THE HIFU THERAPY OR THROUGH A COMBINATION OF BOTH FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837870 SONALLEVE MR-HIFU MR-GUIDED HIGH INTENSITY FOCUSED ULTRASOUND NRZ PROFOUND MEDICAL INC. 451000080796 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown Required Intervention