BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3210980 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08518
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. 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

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDANT PATIENT EXPERIENCED A GREATER THAN 4 SECOND PAUSE IN PACING WHICH LEAD TO ANTI-TACHYCARDIA PACING (ATP). THERE WAS ALSO NOISE PRESENT ON THE ON THE RIGHT VENTRICULAR (RV) LEAD, AS WELL AS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE, THE RV AND LV LEAD WERE REMOVED AND REPLACED. A NON BOSTON SCIENTIFIC LEAD WAS USED IN THE LV THAT WOULD NOT FIT IN THE CHRONIC DEVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311152 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4555| N119| 4054| 0181