BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 25124465 · Received May 8, 2026

    Report

    Report Number
    3012563838-2026-00024
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 8, 2026
    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

    A REPLACEMENT OF AN IMPLANTED OSM IPG OCCURRED ON (B)(6) 2026. THE DEVICE WAS PREVIOUSLY INVESTIGATED IN (B)(6) 2026 AFTER THE PATIENT REPORTED PROBLEMS CHARGING IT. IMPULSE DYNAMICS (ID) FIELD REPRESENTATIVES TRIED FORCE-CHARGING THE DEVICE BUT WERE UNSUCCESSFUL. HOWEVER, THEY WERE ABLE TO BRING UP THE VOLTAGE OF THE IPG ENOUGH TO WHERE A BRIEF LINK WAS ABLE TO BE ESTABLISHED WITH THE IPG, INDICATING THAT THE IPG WAS IN DOWN MODE. AT THAT POINT, THE PATIENT HAD TO LEAVE FOR ANOTHER DOCTOR'S APPOINTMENT SO THE CHARGING COULD NOT BE CONTINUED. THE DOWN MODE ERROR CODE THAT WAS DISPLAYED WAS ""DOWN_ASYMETRIC_PULSES". AT THIS POINT, THE PATIENT WAS GOING TO CIRCLE BACK WITH THEIR CARDIOLOGIST ABOUT A PLAN OF ACTION. THEY ULTIMATELY DECIDED TO HAVE THE IPG REPLACED, WHICH OCCURRED ON (B)(6) 2026. THE EXPLANTED IPG IS CURRENTLY BEING DECONTAMINATED AT AN APPROVED DECONTAMINATION FACILITY. IT WILL THEN BE RETURNED TO ID USA IN MARLTON, NJ FOR A FULL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31672 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4701 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other