BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1874055 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18882
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    March 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. A REVIEW OF DEVICE'S MEMORY FOUND STORED EPISODES AFTER (B)(6) 2010. MICROSCOPIC VISUAL INSPECTION VERIFIED THAT THE HEADER WAS INTACT AND NO DAMAGE TO THE SEAL PLUGS WERE IDENTIFIED. 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. IT WAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD DIED IN (B)(6) 2011. THERE WERE NO ALLEGATIONS OR COMPLAINT AGAINST THE DEVICE. NO REASONABLE EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THIS PATIENT. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT IN (B)(6) 2013.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS HEALTH CARE PROVIDER (HCP) CONTACTED TECHNICAL SERVICES TO DISCUSS A POST-IMPLANT VENTRICULAR FIBRILLATION (VF) EPISODE FOR WHICH NO THERAPY WAS DELIVERED. ALTHOUGH THE DEVICE COUNTER WAS INCREMENTED, THERE WAS NO EPISODE AVAILABLE IN THE ARRHYTHMIA LOGBOOK. TECHNICAL SERVICES REQUESTED A SAVE-TO-DISK. THE HCP REPORTED THAT THE ISSUE APPEARS TO BE RELATED TO THE LACK OF SYNCHRONIZATION OF THE DEVICE AND PROGRAMMER. THE DATE OF THE PROGRAMMER WAS SET AT 2009 INSTEAD OF 2010. THE HCP WOULD LIKE TO REVIEW THE VF EPISODE TO DETERMINE WHY NO THERAPY WAS DELIVERED. THE PATIENT IS AWAITING A NEW COMMUNICATOR SO THAT A PATIENT INITIATED INTERROGATION (PII) CAN BE PERFORMED.

    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 76 YR (B)(4)| (B)(4)| (B)(4)