BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 18178109 · Received November 20, 2023

    Report

    Report Number
    3012563838-2023-00019
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    September 5, 2023
    Report Date
    November 20, 2023
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    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

    DURING A FOLLOW-UP VISIT ON (B)(6) 2023, AN IMPULSE DYNAMICS (ID) FIELD REPRESENTATIVE WAS NOTIFIED BY THE HOSPITAL OF A PATIENT WITH AN IMPLANTED OPTIMIZER SMART MINI DEVICE WHOSE IMPLANTABLE PULSE GENERATOR (IPG) HAD ENTERED "CCM DOWN MODE". FIELD STAFF WERE DISPATCHED AND INTERROGATED THE PATIENT'S IPG, WHICH YIELDED THE ERROR MESSAGE: "TELEMET ERROR: DOWN_ TEMPERA TURE_INTEGRITY 3" ERROR. THE IPG WAS RESET AND REPROGRAMMED, BUT ON (B)(6) 2023, THE PATIENT CONTACTED THE ID FIELD REPRESENTATIVE TO REPORT AN A09 ERROR CODE APPEARING ON THEIR CHARGER. THE DEVICE WAS AGAIN RESET AND REPROGRAMMED BY ID FIELD STAFF, BUT THE ERROR CODE APPEARED AGAIN ON (B)(6) 2023. INTERROGATION OF THE IPG IN BOTH INSTANCES YIELDED A "TELEMET ERROR: DOWN_CHARGE_CURRENT_TOO_HIGH" ERROR MESSAGE. THE IPG WAS AGAIN RESET AND RETURNED TO NORMAL FUNCTION. ANALYSIS OF THE IPG LOG FILES CONFIRMED THIS IS THE SAME, KNOWN HIGH CHARGE CURRENT ISSUE THAT HAS AFFECTED SEVERAL OTHER IPGS, AND THE PATIENT WAS ADVISED TO CHARGE THEIR IPG ONLY TO 75 PERCENT BATTERY CAPACITY (3 OF 4 BARS DISPLAYED ON THE CHARGER) TO AVOID THE IPG ENTERING DOWN MODE AGAIN. THE PERMANENT FIX FOR THIS ISSUE WILL BE IMPLEMENTED AS PART OF A FUTURE FIRMWARE UPDATE THAT IS CURRENTLY PENDING FINALIZATION BEFORE BEING SUBMITTED TO FDA FOR REVIEW AND APPROVAL. THE PATIENT DID NOT FOLLOW THIS ADVISEMENT, THOUGH IT IS UNCLEAR IF THIS WAS INTENTIONAL OR UNINTENTIONAL, AND THEIR IPG ENTERED DOWN MODE AGAIN ON (B)(6) 2023. AT THIS TIME, THE PATIENT REFUSED ALL REQUESTS TO HAVE THEIR DEVICE INTERROGATED AND INSISTED ON HAVING THE IPG REMOVED. AFTER CONSULTING WITH THE IMPLANTING PHYSICIAN ON (B)(6) 2023, THE PATIENT'S IPG WAS REMOVED/EXPLANTED ON SEPTEMBER 5, 2023 WITH NO ISSUES OR COMPLICATIONS. THE IPG EXHIBITED NO PHYSICAL OR FITMENT ISSUES AND WAS SHIPPED TO IMPULSE DYNAMICS USA, INC. FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796684 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4767 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other MEDTRONIC DR DEFIBRILLATOR.