BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2060002 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05756
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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. AN IS-1/DF-1 TEST LEAD WAS PLACED INTO EACH PORT. MICROSCOPIC EVALUATION WAS ABLE TO SEE EACH LEAD BEYOND THE CONNECTOR BLOCK, AND WHEN TIGHTENED DOWN THE SETSCREW, THE LEADS ALL PASSED THE TUG TEST; WERE SECURED AND COULD NOT BE PULLED OUT. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE DEVICE RECORDED OUT OF RANGE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) IMPEDANCES OF GREATER THAN 2,000 OHMS. IT WAS NOTED THAT THE PHYSICIAN PERFORMED MULTIPLE REINSERTIONS OF THE LEADS, AND COULD VISUALIZE THE TERMINAL PINS, AND PASSED THE TUG TEST; HOWEVER, MEASUREMENTS REMAINED GREATER THAN 2,000 OHMS. THE DEVICE WAS THEREFORE REMOVED AND A NEW CRT-D WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR T135| 0157| 0158| 1181| 4542| T177| H170| (B)(4)| 4471| (B)(4)