BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3052614 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04658
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    September 21, 2009
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO POST MARKET RELIABILITY LABORATORY FOR ROUTINE ANALYSIS. IT WAS DOCUMENTED THAT THIS PRODUCT AND THE ASSOCIATED LEADS WERE EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155304 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4542| 0184| 4135| N119