BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23478690 · Received November 5, 2025

    Report

    Report Number
    3012563838-2025-00024
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 5, 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

    Narratives

    Description of Event or Problem · 0

    ON NOVEMBER 4, 2025, IMPULSE DYNAMICS REGULATORY STAFF WERE NOTIFIED OF AN EXPLANT THAT WAS DISCOVERED BY AN ID FIELD REPRESENTATIVE HAD TAKEN PLACE ON (B)(6) 2025. THE FOLLOWING INFORMATION WAS PROVIDED: "IMPLANTING PHYSICIAN REACHED OUT THAT [PATIENT] HAD ENDOCARDITIS AND WAS SEPTIC. BOTH [THEIR] DEFIBRILLATOR ON [THEIR] LEFT SIDE AND [THEIR] OPTIMIZER ON THE RIGHT SIDE WERE GOING TO BE REMOVED. THIS PATIENT HAD MISSED A COUPLE OF CLINICAL VISITS IN A ROW. [IMPULSE] DID NOT EVEN KNOW [PATIENT] WAS IN THE HOSPITAL. NO FAMILY MEMBER REACHED OUT NO CALLS WERE RETURNED. FIRST NOTIFICATION WE HAVE WAS THE DOCTOR TOLD ME THEY WERE REMOVING EVERYTHING DUE TO INFECTION. THEY DO NOT FEEL THIS WAS DEVICE GENERATED." MORE INFORMATION IS CURRENTLY BEING SOUGHT AT THE TIME OF THIS INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637440 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5042 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other