BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19792220 · Received July 22, 2024

    Report

    Report Number
    3012563838-2024-00024
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 19, 2024
    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

    DURING AN IMPLANTATION PROCEDURE FOR AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION DURING INITIAL LEAD POSITIONING. AT THIS POINT IN THE PROCEDURE, THE IPG HAD NOT YET BEEN IMPLANTED IN THE PATIENT AND THE IPG WAS STILL BEING CONFIGURED ON THE BACK TABLE. THE PATIENT RECEIVED DC CARDIOVERSION THAT WAS SUCCESSFUL IN NORMALIZING THEIR HEART RHYTHM. THE IMPLANTATION PROCEDURE CARRIED ON WITHOUT FURTHER INTERRUPTIONS AND THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH AN OSM IPG. THE PATIENT WAS REPORTEDLY STABLE POST-OP AND WAS DISCHARGED FROM THE HOSPITAL LATER THAT SAME DAY. THE PATIENT HAS NOT REPORTED ANY PROBLEMS OR INCIDENTS PERTAINING TO THEIR CONDITION OR THEIR OSM IPG SINCE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187934 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5140 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other