BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23372828 · Received October 23, 2025

    Report

    Report Number
    3012563838-2025-00022
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 23, 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

    ON SEPTEMBER 24, 2025, A REPORT FROM AN IMPULSE DYNAMICS FIELD REPRESENTATIVE BASED IN ITALY WAS RECEIVED THAT AN OSM IPG REPLACEMENT HAD OCCURRED. THE PATIENT HAD PREVIOUSLY BEEN SEEN FOR AN ERROR CODE DISPLAYED WHILE ATTEMPTING TO CHARGE THE IPG, BUT AT THE TIME OF VISIT, THE DEVICE COULD NOT BE INTERROGATED BY ID REPRESENTATIVES. IT WAS THEN DECIDED BY THE PHYSICIANS TO REPLACE THE PATIENT'S IMPLANTED IPG. IN ADDITION, THE PHYSICIANS DECIDED THAT, AT THE SAME TIME AS THE IPG REPLACEMENT, THEY WOULD IMPLANT AN ICD VR/DX. THE PATIENT HAS AGREED TO THE PROPOSED PLAN, AND THE REVISION PROCEDURE OCCURRED ON (B)(6) 2025. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT HAS NOT EXPERIENCED ANY PROBLEMS POST-OP. THE EXPLANTED IPG IS EXPECTED TO BE RECEIVED BY IMPULSE DYNAMICS USA IN MARLTON, NJ IN THE COMING WEEKS FOR TECHNICAL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2817142 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5182 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other