BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 18084076 · Received November 7, 2023

    Report

    Report Number
    3012563838-2023-00003
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    April 10, 2023
    Report Date
    November 7, 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

    ON SEPTEMBER 12, 2022, THE IMPULSE DYNAMICS TECHNICAL SERVICE LINE RECEIVED A CALL FROM A PATIENT WHO WAS EXPERIENCING AN ABNORMAL STATUS CONDITION ALERT ON THEIR CHARGER. THE CHARGER INDICATED THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) DEVICE HAD ENTERED "CCM DOWN MODE". FIELD STAFF WERE DISPATCHED AND INTERROGATED THE PATIENT'S IPG, WHICH YIELDED A "TELEMET ERROR: DOWN_CHARGE_CURRENT_TOO_HIGH" ERROR. THE IPG WAS RESET AND REPROGRAMMED, BUT CONTINUED TO GENERATE THE SAME ERROR AND ENTER DOWN MODE EVEN AFTER A NEW CHARGER WAS USED. FURTHER ANALYSIS OF THE DEVICE LOG FILES, TELEMETRY VERSIONS, PROGRAMMER SCREEN CAPTURES, AND OTHER RELEVANT INFORMATION REVEALED THIS ERROR WOULD ONLY MANIFEST WHEN THE IPG BATTERY WAS CHARGED ABOVE 75 PERCENT. UPON THIS DISCOVERY, THE PATIENT WAS INSTRUCTED TO CHARGE THEIR IPG ONLY TO 75 PERCENT OF FULL BATTERY CAPACITY (3 OF 4 BARS). 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. AFTER SEVERAL MONTHS, THE PATIENT OPTED TO HAVE THEIR IPG REMOVED AND REPLACED WITH A NEW ONE RATHER THAN CONTINUE TO CHARGE THE IPG TO 75 PERCENT. THE IPG WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH NO ISSUES OR COMPLICATIONS. BOTH THE IPG AND ATTACHED LEADS EXHIBITED NO PHYSICAL OR FITMENT ISSUES AND WERE SHIPPED TO IMPULSE DYNAMICS USA, INC. FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351292 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4812 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other