BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23687099 · Received December 1, 2025

    Report

    Report Number
    3012563838-2025-00029
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 1, 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

    IMPULSE DYNAMICS STAFF WERE MADE AWARE ON NOVEMBER 4, 2025, THAT ABOUT 2.5 WEEKS PRIOR ON (B)(6) 2025, A REPLACEMENT PROCEDURE OCCURRED FOR A PATIENT IN (B)(6) IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED IPG HAD PREVIOUSLY BEEN INVESTIGATED BY IMPULSE DYNAMICS FIELD STAFF IN AUGUST 2025 FOR THE REPORTED INABILITY OF THE DEVICE TO BE CHARGED OR INTERROGATED AFTER THE PATIENT REPORTED THEY FORGOT TO CHARGE THE DEVICE AFTER BEING ON VACATION FOR THREE WEEKS. A CHARGE CONNECTION COULD NOT BE ESTABLISHED WITH THE IPG IRRESPECTIVE OF WHAT/ANY CHARGER THAT WAS USED DURING SUBSEQUENT FOLLOW-UP VISITS IN (B)(6) 25. THE DECISION WAS THEN MADE BY THE IMPLANTING PHYSICIAN TO REPLACE THE PATIENT'S IPG, WHICH OCCURRED AS NOTED PREVIOUSLY. THE IPG COULD NOT BE CHARGED OR INTERROGATED PRIOR TO EXPLANT. THE DEVICE IS CURRENTLY UNDERGOING DECONTAMINATION AT AN APPROVED DECONTAMINATION FACILITY. IT WILL BE RETURNED TO IMPULSE DYNAMICS USA IN MARLTON, NEW JERSEY FOR EVALUATION ONCE DECONTAMINATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114258 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5094 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other