BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 21537931 · Received March 6, 2025

    Report

    Report Number
    3012563838-2025-00005
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    January 11, 2024
    Report Date
    March 6, 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 10, 2025, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED THAT A PATIENT IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) HAD THEIR IPG AND LEADS EXTRACTED ON (B)(6) 2024. THE HOSPITAL CITED THE IPG WAS REMOVED DUE TO A "NON DEVICE RELATED" INFECTION THAT THE PATIENT HAD DEVELOPED. THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL AND WAS NOT AVAILABLE FOR EVALUATION. THERE IS NO INFORMATION TO SUGGEST THE IPG CAUSED OR CONTRIBUTED TO THE INFECTION LEADING TO DEVICE REMOVAL. 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
    813212 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5010 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other