BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 22494407 · Received July 14, 2025

    Report

    Report Number
    3012563838-2025-00013
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 14, 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

    IMPULSE DYNAMICS WAS MADE AWARE ON JUNE 22, 2025 THAT THIS DEVICE HAD BEEN EXPLANTED ON (B)(6) 2025 DUE TO "AN INFECTION AT THE AREA OF THE IPG." THE TYPE AND SUSPECTED SOURCE OF THIS PATIENT INFECTION ARE CURRENTLY UNKNOWN. THE EXPLANTED DEVICE IS CURRENTLY BEING SOUGHT FOR EVALUATION. A REVIEW OF THE OHR WAS CONDUCTED AND FOUND NO ANOMALIES, INCLUDING ANY IN THE STERILIZATION RECORDS. THE TYPE AND SUSPECTED SOURCE OF THIS PATIENT INFECTION ARE CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856012 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5237 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other