BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23851848 · Received December 19, 2025

    Report

    Report Number
    3012563838-2025-00031
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 19, 2025
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE ON (B)(6) 2025 THAT DURING A LEAD REVISION PROCEDURE THAT DAY, BOTH LEADS WERE BEING REMOVED FROM THE IMPLANTED OSM IPG HEADER WHEN IT WAS NOTED THAT THE IPG SET SCREWS HAD BEEN BACKED OUT TOO FAR. ONE SET SCREW WAS SUCCESSFULLY RESEATED, BUT THE SECOND SCREW FAILED TO ENGAGE PROPERLY. DESPITE SEVERAL ATTEMPTS BY THE PHYSICIAN TO RESEAT THE SCREW, THE SCREW COULD NOT BE RESEATED, AND A NEW DEVICE WAS REQUESTED. A REPLACEMENT IPG WAS PROVIDED AND FUNCTIONED AS INTENDED. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED TO IMPULSE DYNAMICS USA IN MARLTON, NJ IN THE COMING WEEKS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259107 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5208 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other