BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 20591622 · Received November 1, 2024

    Report

    Report Number
    3012563838-2024-00036
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 1, 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 OCTOBER 7, 2024, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE RECEIVED NOTIFICATION THAT AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) HAD BEEN EXTRACTED DUE TO PATIENT INFECTION. THE INFECTION WAS A VEGETATION INFECTION ASSOCIATED WITH THE PATIENT'S CONCOMITANT CRT-D DEVICE. BOTH THE CRT-D AND OSM IPG DEVICES WERE EXPLANTED AS A PRECAUTION. THE EXPLANT PROCEDURE FOR BOTH DEVICES ''WENT WELL" WITHOUT ANY SURGICAL OR PATIENT-RELATED COMPLICATIONS. THE OSM IPG WAS DISCARDED AND WILL THUS NOT BE AVAILABLE FOR EVALUATION. A REVIEW OF THE IPG'S OHR INCLUDING STERILIZATION RECORDS UNCOVERED NO ANOMALIES. THERE IS NO EVIDENCE TO SUGGEST THE OSM IPG CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799949 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4948 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other