BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19006479 · Received March 29, 2024

    Report

    Report Number
    3012563838-2024-00014
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 29, 2024
    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 MARCH 1, 2024, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED THAT A PATIENT'S OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) DEVICE AND ITS CONNECTED LEADS WERE EXPLANTED. THE PATIENT HAD DEVELOPED AN INFECTION, THUS LEADING TO THE DECISION BY THE IMPLANTING PHYSICIAN TO EXPLANT THE !PG AND LEADS. THE INFECTION WAS SUSPECTED TO BE STAPHYLOCOCCUS, BUT THE RESULTS OF THE SWAB AND CULTURE TESTING PERFORMED BY THE HOSPITAL HAVE NOT BEEN MADE AVAILABLE TO IMPULSE DYNAMICS AT THE LIME OF THIS REPORT. THE IPG WAS PACKAGED AND SENT TO IMPULSE DYNAMICS USA, INC. FOR EVALUATION AND TO CONFIRM THE IPG WAS FULLY FUNCTIONAL AT THE LIME OF EXPLANT. AFTER THE IPG WAS DECONTAMINATED AT AN APPROVED DECONTAMINATION FACILITY, IT WAS RETURNED TO IMPULSE DYNAMICS USA FOR EVALUATION ON MARCH 18, 2024. THE DEVICE PASSED ALL FINAL ELECTRONIC CONTROLS TESTING AND NO MALFUNCTIONS WERE OBSERVED. DEVICE LOGS INDICATED THAT NO DEVICE FAILURE HAD EVER OCCURRED. ALL SET SCREWS WERE OPERATIONAL WHEN TESTING WAS PERFORMED. A REVIEW OF DEVICE STERILIZATION RECORDS WAS CONDUCTED AND NO ANOMALIES WERE FOUND. THERE IS NO EVIDENCE TO INDICATE THE IPG WAS NOT FULLY FUNCTIONAL AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259096 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5085 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other