BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 23073689 · Received September 17, 2025

    Report

    Report Number
    3012563838-2025-00019
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 17, 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 (B)(6) 2025, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED THAT A PATIENT IMPLANTED WITH AN OSM IPG HAD THEIR DEVICE EXPLANTED DUE TO AN INFECTION HAVING DEVELOPED IN THE "SURROUNDING AREA" OF THE DEVICE. IT WAS FURTHER REPORTED THE PATIENT'S IPG HAD BEEN "POPPING OUT OF [THEIR] SKIN" PRIOR TO EXPLANT. THERE ARE CURRENTLY NO PLANS TO IMPLANT A NEW DEVICE IN THIS PATIENT. IT IS UNKNOWN AT THIS TIME IF THE EXPLANTING HOSPITAL DISCARDED THE IPG OR IF IT WOULD BE AVAILABLE FOR EVALUATION; THIS INFORMATION IS CURRENTLY BEING SOUGHT. THE NATURE AND TYPE OF INFECTION IS LIKEWISE UNKNOWN AT THIS TIME. A DHR REVIEW WAS CONDUCTED, AND NO ANOMALIES WERE FOUND, INCLUDING ANY IN THE DEVICE STERILIZATION RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649290 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4916 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other