BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2081054 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08051
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 30, 2011
    Report Date
    August 15, 2011
    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, 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 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. LEADS WERE INSERTED INTO ALL PORTS WITHOUT DIFFICULTY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THIS MEDICAL DEVICE WAS ELECTIVELY DEACTIVATED DUE TO CUSTOMER DISSATISFACTION. THE CUSTOMER DID NOT WANT TO SET OFF STORE ALARMS ANY MORE.

    Additional Manufacturer Narrative · 1

    TO DATE, AVAILABLE INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IMPLANTED. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEACTIVATED FOR UNKNOWN REASON. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION, BUT NONE IS AVAILABLE TO DATE.

    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 51 YR 4543| 4470| 0187| 0184| N119| H210| 4549