BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23221570 · Received October 6, 2025

    Report

    Report Number
    3012563838-2025-00020
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 6, 2025
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    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

    A REPORT WAS RECEIVED ON (B)(6) 2025 FROM AN IMPULSE DYNAMICS FIELD REPRESENTATIVE THAT DURING A LEAD REVISION PROCEDURE EARLIER THAT DAY, THE V1 LEAD PORT ON THE OSM IPG STARTED TO GENERATE CONSISTENT NOISE. THE LEAD WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES, BUT THE PORT CONTINUED TO HAVE NOISE. EVEN AFTER SWAPPING LEADS ENTIRELY, THE NOISE STAYED ON THE V1 PORT. THE IPG WAS SWAPPED OUT FOR A NEW ONE, AND THE NEW IPG SHOWED NO NOISE ON EITHER PORT. IT IS UNCLEAR AT THIS TIME WHY THE ORIGINAL OSM IPG, WHICH HAD BEEN IMPLANTED IN THE PATIENT MORE THAN THREE MONTHS PRIOR, NEVER PREVIOUSLY GENERATED NOISE ON THE V1 PORT BUT STARTED DOING SO DURING THIS PROCEDURE. AFTER BEING DECONTAMINATED AT AN APPROVED DECONTAMINATION FACILITY, THE EXPLANTED DEVICE WAS RECEIVED BY ID USA FOR FURTHER EVALUATION ON SPETEMBER 19, 2025. A FULL PRODUCT EVALUATION IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460413 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other