BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 18700215 · Received February 13, 2024

    Report

    Report Number
    2124215-2024-08537
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    December 11, 2023
    Report Date
    September 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A PRODUCT PERFORMANCE ISSUE OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A PRODUCT PERFORMANCE ISSUE OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED IMPEDANCE INCREASES UP TO 1638 OHMS FROM 530 OHMS ON THE ATRIAL LEAD, WHICH IS STILL WITHIN NORMAL LIMITS. THE IMPEDANCE INCREASES HAVE BECOME MORE FREQUENT OVER THE LAST TWO MONTHS. THE PRESENTING ELECTROGRAM (EGM) SHOWS APPROPRIATE FUNCTION. THE ATRIAL LEAD IS A COMPETITOR PRODUCT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED IMPEDANCE INCREASES UP TO 1638 OHMS FROM 530 OHMS ON THE ATRIAL LEAD, WHICH IS STILL WITHIN NORMAL LIMITS. THE IMPEDANCE INCREASES HAVE BECOME MORE FREQUENT OVER THE LAST TWO MONTHS. THE PRESENTING ELECTROGRAM (EGM) SHOWS APPROPRIATE FUNCTION. THE ATRIAL LEAD IS A COMPETITOR PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE CRT-D RECORDED AN ALERT FOR ATRIAL PACING LEAD IMPEDANCE HIGH OUT OF RANGE. RHYTHMCARE DISCUSSED THE 12-MONTH LEAD TREND SHOWS GREATER THAN 30% OF VARIATION IN IMPEDANCE, WITH A RANGE OF 480-2108 OHMS, WHICH IS HIGH OUT OF RANGE. THE SENSING AND THRESHOLD TREND ARE SATISFACTORY. FURTHER REVIEW WAS RECOMMENDED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338456 AUTOGEN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G179 158772

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown