BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19471670 · Received June 5, 2024

    Report

    Report Number
    3012563838-2024-00021
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 5, 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 OCTOBER 26, 2023.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT IN GERMANY IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) CALLED THE IMPULSE DYNAMICS TECHNICAL SUPPORT HOTLINE TO REPORT THAT AN A9 ERROR HAD APPEARED ON THEIR IPG CHARGER WHEN THEY ATTEMPTED TO CHARGE THE IPG. THE PATIENT WAS SEEN THE NEXT DAY BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WHO INTERROGATED AND RESET THE PATIENT'S IPG. 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'S IPG WAS THEN UPGRADED TO THE LATEST 1.11.0 FIRMWARE, WHICH IS NOW ALSO APPROVED AND AVAILABLE IN THE EU. THIS FIRMWARE CONTAINS THE PERMANENT FIX FOR THIS HCC ISSUE, AS DOCUMENTED IN PREVIOUS COMMUNICATIONS BETWEEN IMPULSE DYNAMICS AND FDA. 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
    1523389 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male