BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 20075992 · Received August 27, 2024

    Report

    Report Number
    3012563838-2024-00029
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    March 4, 2025
    Report Date
    March 24, 2025
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN EXPLANT PROCEDURE TOOK PLACE FOR A PATIENT WHO HAD BEEN IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) OVER A YEAR AGO. THE PROCEDURE WAS PERFORMED AT THE BEHEST OF THE PATIENT'S ELECTROPHYSIOLOGIST (EP), WHO REPLACED THE PATIENT'S OSM IPG WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE. THE PATIENT'S EP CHOSE TO REMOVE THE PATIENT'S OSM IPG BECAUSE THEY BELIEVED THE PATIENT'S INCREASING COGNITIVE CHALLENGES WOULD PRECLUDE THEIR ABILITY TO KEEP THEIR OSM IPG CHARGED. THE EXPLANTED IPG HAS NOT YET BEEN RECEIVED BY IMPULSE DYNAMICS USA BUT IS EXPECTED TO BE RECEIVED, DECONTAMINATED, AND EVALUATED IN THE COMING WEEKS. THERE IS NO EVIDENCE TO SUGGEST THE IPG WAS MALFUNCTIONING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. ON (B)(6) 2025, II WAS CONFIRMED THAT THE EXPLANTED OSM IPG HAD BEEN SCRAPPED BY THE HOSPITAL. THEREFORE, A FULL PRODUCT EVALUATION OF THE DEVICE WILL NOT BE POSSIBLE. THERE REMAINS NO EVIDENCE TO SUGGEST THE IPG WAS MALFUNCTIONING AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219613 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4686 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other