BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 4140013 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16440
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE FIELD, THE CRT-D WILL NOT BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR RIGHT ATRIAL (RA) LEAD EXHIBITED A HIGH PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS. RA THRESHOLDS WERE ALSO SLIGHTLY ELEVATED. ALL OTHER LEAD DIAGNOSTICS WERE NORMAL AND THE PATIENT IS NOT PACER DEPENDENT SO NO PROGRAMMING CHANGES WERE MADE. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THE IMPEDANCE ISSUE IS THOUGHT TO BE DUE TO THE RA LEAD, HOWEVER NO CONCLUSIVE CAUSE IS KNOWN AT THIS TIME. THE CRT-D CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT SURGICAL INTERVENTION WAS PERFORMED AND THE CRT-D AND RA LEAD WERE EXPLANTED AND REPLACED DUE TO THE CLINICAL OBSERVATIONS IN THIS EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619633 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N107

    Patients

    Seq Age Sex Outcome Treatment
    1 4574| N107