BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 21415022 · Received February 19, 2025

    Report

    Report Number
    3012563838-2025-00003
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    November 1, 2023
    Report Date
    February 19, 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 FEBRUARY 6, 2025, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED THAT A PATIENT IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) HAD CONTRACTED AN "ENTEROCOCCUS FAECALIS SEPTICEMIA" BLOOD INFECTION, AND THE IPG AND LEADS WERE EXTRACTED ON (B)(6) 2023. THE PATIENT LATER RECEIVED A NEW OSM IPG, WHICH REMAINS IMPLANTED TO THIS DAY. THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL AND WAS NOT AVAILABLE FOR EVALUATION. THERE IS NO INFORMATION TO SUGGEST THE ORIGINAL IPG CAUSED OR CONTRIBUTED TO THE PATIENT'S BLOOD INFECTION; THE REMOVAL WAS DEEMED PROPHYLACTIC. A REVIEW OF THE OHR INCLUDING DEVICE STERILIZATION RECORDS DID NOT UNCOVER ANY ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178918 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4715 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other