BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23361160 · Received October 22, 2025

    Report

    Report Number
    3012563838-2025-00021
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 22, 2025
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A REPORT FROM AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS RECEIVED ON SEPTEMBER 23, 2025 STATING THAT AN OSM IPG HAD BEEN REPLACED DURING A LEAD REVISION PROCEDURE. THE PATIENT HAD ORIGINALLY PRESENTED TO THE CLINIC FOR A 1-MONTH POST-OP WOUND CHECK AND WAS FOUND TO BE IN NEED OF A LEAD REVISION FOR THE V1 LEAD. DURING THE LEAD REVISION PROCEDURE ON (B)(6) 2025, UPON RECONNECTING THE NEW LEADS TO THE DEVICE AND ATTEMPTING TO BEGIN CCM DELIVERY, AN ANOMALY WAS DISPLAYED IN WHICH THE RV AND LS SIGNALS SEPARATED. THE DECISION WAS MADE BY THE IMPLANTING TEAM TO REPLACE THE OSM IPG IN CASE THIS ISSUE WITH SIGNAL SEPARATION COULD BE TIED TO THE IPG AND NOT THE LEADS. THE NEW IPG WAS IMPLANTED WITHOUT INCIDENT AND THE PATIENT HAS NOT REPORTED ANY MEDICAL OR OPERATIONAL ISSUES SINCE THE PROCEDURE. THE EXPLANTED IPG WAS SENT TO AN APPROVED DECONTAMINATION FACILITY, AND THE DECONTAMINATED DEVICE WAS RECEIVED BY IMPULSE DYNAMICS USA IN MARLTON, NJ ON OCTOBER 6, 2025. THE PRODUCT EVALUATION IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231500 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5332 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other