BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 20618261 · Received November 6, 2024

    Report

    Report Number
    1000165971-2024-01043
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 9, 2024
    Report Date
    January 29, 2025
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    UDI-DI
    08031527012919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF PROVIDED DATA CONFIRMED THE REPORTED EVENT: THE BATTERY IMPEDANCE INCREASED BY 8 KOHMS IN 8 MONTHS. THIS BEHAVIOUR IS NORMAL BEHAVIOUR WHEN REACHING THE RRT (RECOMMENDED REPLACEMENT TIME): THE BATTERY IMPEDANCE CURVE PRESENTS WITH AN EXPONENTIAL PROFILE. THE PROVIDED DATA WERE ANALYSED AND THE RESIDUAL LONGEVITY WAS 13 MONTHS (MIN 8 MONTHS) ON (B)(6) 2024. ON (B)(6) 2024, THE DEVICE HAD REACHED THE RRT. THE TOTAL NUMBER OF CYCLES FROM (B)(6) 2024 TO (B)(6) 2024 IS 20 717 387 CYCLES (TIME IN DDD MODE AND IN VVI MODE POST SWITCH TO RRT). FROM THE PROVIDED EXPERT DATA; IT HAS BEEN SEEN THAT THE NUMBER OF CYCLES IN MODE SWITCH WAS 17 881 416 CYCLES (DDD ¿ DDI PACING MODE), CORRESPONDING TO 86,3% OF THE TOTAL NUMBER OF CYCLES. BASED ON THE ANALYSIS OF THE NUMBER OF CYCLES, WE SUSPECT THAT THE RRT WAS REACHED BEGINNING OF (B)(6) 2024, LEADING TO 6,5 MONTHS BEFORE RRT SINCE (B)(6) 2024, INSTEAD OF THE 8 MONTHS MINIMUM THAT WERE DISPLAYED ON (B)(6) 2024. THE MOST PROBABLE EXPLANATION OF THE DIFFERENCE OF DISPLAYED TIME TO RRT ON 15 FEBRUARY 2024 AND THE SWITCH TO RRT IN (B)(6) 2024 (DIFFERENCE OF 1-1,5 MONTH) IS THE FACT THAT THE DEVICE WAS IN MODE SWITCH, I.E. THE DEVICE WAS DETECTING ATRIAL FIBRILLATION, TRIGGERING AN INCREASED CONSUMPTION DUE TO THE ATRIAL SIGNAL DETECTION AND SAMPLING. SINCE HISTORICAL FOLLOW-UP DATA FROM (B)(6) 2019, (B)(6) 2023, (B)(6) 2023 AND (B)(6) 2024 HAVE BEEN PROVIDED, THE ESTIMATION OF THE OVERALL LONGEVITY COULD BE PERFORMED. BASED ON AVAILABLE DATA, THE EXPECTED OVERALL LONGEVITY IS ESTIMATED AT ¿ 105 MONTHS. THE IMPLANTATION DURATION WAS 87,6 MONTHS WHICH IS HIGHER THAN 75% OF THE ESTIMATED OVERALL LONGEVITY (75% OF 105 MONTHS = 78,7 MONTHS). BASED ON HRS GUIDELINES, NO PREMATURE BATTERY DEPLETION OCCURRED. NO GENERAL MALFUNCTION IS SUSPECTED ON THE SUBJECT DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE INITIAL INVESTIGATION ON THE LONGEVITY CALCULATION DOESN'T SHOW ANY ISSUE. THE MANUFACTURING PROCESS AS WELL AS DEVICE HISTORY REPORTS SHOW THAT THE DEVICE HAS BEEN MANUFACTURED AND DELIVERED TO THE FIELD FOLLOWING ALL APPLICABLE PROCEDURES.

    Description of Event or Problem · 0

    REPORTEDLY, THIS PACEMAKER BATTERY IMPEDANCE WAS 3KOHM IN FEBRUARY. THE ESTIMATED MINIMUM LONGEVITY WAS 9 MONTHS (IN FEBRUARY). ON (B)(6) 2024, THE PACEMAKER BATTERY IMPEDANCE IS 11 KOHM. 8 KOHM HAVE BEEN LOST IN 8 MONTHS.

    Description of Event or Problem · 0

    REPORTEDLY, THIS PACEMAKER BATTERY IMPEDANCE WAS 3KOHM IN FEBRUARY. THE ESTIMATED MINIMUM LONGEVITY WAS 9 MONTHS (IN FEBRUARY). ON (B)(6) 2024, THE PACEMAKER BATTERY IMPEDANCE IS 11 KOHM. 8 KOHM HAVE BEEN LOST IN 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860571 KORA IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. KORA 250 DR 08031527012919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown