BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173684 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12216
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    December 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED OR UPON COMPLETION OF ANALYSIS.

    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. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    A RECENT REVIEW OF DEVICE MEMORY NOTED THE DEVICE HAD RECORDED ONE OR TWO FAULTS THAT WERE MOST LIKELY CAUSED BY THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A TRICUSPID VALVE RECONSTRUCTION AND MITRAL VALVE REPLACEMENT PROCEDURE. DURING THE PROCEDURE, A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED ON THE LEFT VENTRICULAR LEAD, AND BOTH NOISE AND OVERSENSING WERE NOTED ON THE RIGHT VENTRICULAR LEAD. ALL LEADS WERE REMOVED BY LASER EXTRACTION. WHEN A NEW RIGHT VENTRICULAR LEAD WAS CONNECTED TO THE DEVICE, ANOTHER HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED. THIS DEVICE WAS REMOVED. WHEN AND A NEW DEVICE WAS CONNECTED TO THE NEW RIGHT VENTRICULAR LEAD, ALL MEASUREMENTS WERE NORMAL. THE CRT-D WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR P107| 0185| 4512| 0181