BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23501201 · Received November 7, 2025

    Report

    Report Number
    3012563838-2025-00025
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    December 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NOTE: THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. THE EXPLANTED IPG WAS RETURNED TO ID USA FOR A FULL EVALUATION AFTER BEING STERILIZED. A LOOSE SET SCREW WAS OBSERVED WHICH WAS CONSISTENT WITH THE REPORTED ISSUE. THE REMAINING FIVE SET SCREWS WERE SUCCESSFULLY TIGHTENED TO FULL DEPTH AND BACKED OUT WITHOUT ISSUE. THE LOOSE SET SCREW WAS REPLACED IN ORDER FOR THE IPG TO BEGIN ELECTRONIC CONTROLS TESTING. THE DEVICE PASSED ALL FUNCTIONAL CHECKS OF THE FINAL ELECTRONIC CONTROL TESTING. THE ROOT CAUSE OF THIS ISSUE WAS USER ERROR DURING THE IMPLANT PROCEDURE. THE IPG WAS SCRAPPED AFTER EVALUATION.

    Description of Event or Problem · 0

    DURING A LEAD REVISION PROCEDURE ON (B)(6) 2025, IT WAS REPORTED BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE THAT THE PHYSICIAN DURING THE PROCEDURE HAD BACKED OUT THE OSM IPG SET SCREW TOO FAR WHEN ATTACHING THE NEW LEAD. THE SCREW WAS BACKED OUT TO THE POINT WHERE "IT WAS TILTED AND OUT OF THE GROOVES." THE PHYSICIAN AT THAT POINT SWAPPED THE PREVIOUSLY IMPLANTED IPG FOR A NEW ONE. THE EXPLANTED IPG IS EXPECTED TO BE RECEIVED BY IMPULSE DYNAMICS USA, INC. IN MARLTON, NJ IN THE COMING WEEKS FOR A FULL PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925007 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4828 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male