BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19899425 · Received August 2, 2024

    Report

    Report Number
    3012563838-2024-00025
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 2, 2024
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    PMA / PMN Number
    P180036/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED THAT A PATIENT OUTSIDE THE UNITED STATES IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) RECEIVED AN A9 ERROR CODE ON THEIR IPG CHARGER WHEN THEY ATTEMPTED TO CHARGE THEIR IPG. THE PATIENT WAS SEEN BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE THE NEXT DAY WHO RESET THE PATIENT'S IPG. ABOUT AN HOUR AFTER THIS RESET, THE PATIENT REPORTED A SHOCK SENSATION COMING FROM THEIR CONCOMITANT S-ICD. INVESTIGATION OF THE OSM IPG AND S-ICD LOGS REVEALED THE S-ICD LOGS INTERPRETED NOISE IN THE OSM IPG'S CCM SIGNAL. THE S-ICD WAS ALSO DOUBLE-COUNTING THE CCM SIGNAL ON THE T WAVE. THIS MEANS THE OSM IPG HAD TRIGGERED OVERSENSING OF THE S-ICD, RESULTING IN AN INAPPROPRIATE SHOCK. THE S-ICD WAS REPROGRAMMED TO HAVE ITS VECTOR RECALCULATED AND ECG MORPHOLOGY REACQUIRED, BOTH DONE WHILE THE OSM IPG WAS TURNED OFF. THE IPG WAS ALSO REPROGRAMMED TO CHANGE THE TRACKING RATE FROM 110BPM TO 90BPM AND THE VOLTAGE FROM 7.5V TO 7.0V. SINCE BOTH DEVICES WERE REPROGRAMMED, THE PATIENT HAS NOT EXPERIENCED ANY ISSUES WITH THE CONCOMITANT OPERATION OF THEIR OSM IPG AND S-ICD DEVICES. II IS POSSIBLE THAT A CHANGE OF A SETTING OR OTHER PARAMETER DURING THE INITIAL RESET OF THE OSM IPG CONTRIBUTED TO THE S-ICD MISINTERPRETING SIGNALS AND ADMINISTERING AN INAPPROPRIATE SHOCK. THE PROCEDURE FOR CORRECTLY CONFIGURING/RECONFIGURING OSM IPGS IN PATIENTS WITH A CONCOMITANT ICD, INCLUDING REQUIRED INTERACTION TESTING, ARE CAPTURED IN CURRENT DEVICE LABELING. THESE INSTRUCTIONS MUST BE FOLLOWED AS WRITTEN TO ENSURE THE ICD CAN CORRECTLY INTERPRET CCM SIGNALS FROM THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375489 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male