BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19059697 · Received April 8, 2024

    Report

    Report Number
    3012563838-2024-00016
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 8, 2024
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED IN RESPONSE TO THE OUTCOME OF DISCUSSIONS BETWEEN IMPULSE DYNAMICS AND FDA ON (B)(6) 2023.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT IN GERMANY CALLED THE IMPULSE DYNAMICS PATIENT HOTLINE TO REPORT AN A9 ERROR DISPLAYING ON THEIR CHARGER WHILE ATTEMPTING TO CHARGE THEIR SMART MINI IMPLANTABLE PULSE GENERATOR (IPG). AN IMPULSE DYNAMICS FIELD REPRESENTATIVE SAW THE PATIENT THE NEXT DAY ((B)(6)) AND INTERROGATED AND RESET THE DEVICE. UPON INTERROGATION, THE IPG YIELDED A "TELEMET ERROR: DOWN_CHARGE_CURRENT_TOO_HIGH" ERROR. ANALYSIS OF THE IPG LOG FILES CONFIRMED THIS IS THE SAME, KNOWN HIGH CHARGE CURRENT (HCC) ISSUE THAT HAS AFFECTED SEVERAL OTHER IPGS. THE PATIENT WAS ADVISED TO CHARGE THEIR IPG ONLY TO 75 PERCENT BATTERY CAPACITY TO AVOID THE IPG ENTERING DOWN MODE AGAIN. THE RECTIFICATION OF THIS FIRMWARE BUG IS CURRENTLY UNDER REVIEW FOR EU APPROVAL. THE PATIENT HAS BEEN RECEIVING CCM THERAPY AS NORMAL SINCE THE RESET OF THE INITIAL DOWN MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412629 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male