BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 20064662 · Received August 26, 2024

    Report

    Report Number
    3012563838-2024-00028
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 25, 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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON JULY 28, 2024, A PATIENT IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) REPORTED TO AN IMPULSE DYNAMICS FIELD REPRESENTATIVE THAT THEY HAD ENTERED THE EMERGENCY ROOM DUE TO THEIR IPG "ERODING OUT OF [THEIR) CHEST". THE PATIENT'S LOCAL CARDIOLOGIST WAS ALSO MADE AWARE OF THIS EVENT. WHILE THIS IS SUSPECTED AS POCKET EROSION, IT IS UNKNOWN AT THIS TIME EXACTLY WHAT "EROSION" EFFECTS THE PATIENT OBSERVED OR IS CURRENTLY EXPERIENCING. EFFORTS ARE ONGOING TO HAVE THE PATIENT BE SEEN IN-OFFICE BUT HAVE BEEN HAMPERED DUE TO THE PATIENT'S IMPLANTING ELECTROPHYSIOLOGIST NO LONGER PRACTICING IN THE AREA. AN ALTERNATIVE COURSE OF ACTION WILL BE DETERMINED IN WHICH THE PATIENT CAN BE SEEN AND THIS CLAIM CAN BE FURTHER INVESTIGATED.

    Description of Event or Problem · 0

    ON AUGUST 30, 2024, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS ABLE TO ESTABLISH CONTACT WITH THE PATIENT. THE PATIENT STATED THEIR OSM IPG HAD BEEN EXPLANTED 4 WEEKS PRIOR AND THE EXPLANTING SURGEON CONFIRMED THE IPG HAD BEEN IMPLANTED "TOO SUPERFICIALLY", CAUSING POCKET EROSION. THE PATIENT'S CONCOMITANT PACEMAKER WAS ALSO REMOVED AND WILL BE REPLACED. THE PATIENT STATED NEITHER THEY NOR THEIR DOCTOR HAVE A DESIRE TO REPLACE THE EXPLANTED OSM IPG. THE EXPLANTED IPG WAS DISCARDED BY THE HOSPITAL AND WILL THEREFORE NOT BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481842 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4844 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other