BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1771302 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12365
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 4, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE NON-BOSTON SCIENTIFIC LEAD WAS FRACTURED IN THE RATE/SENSE PORTION OF THE LEAD THE PHYSICIAN WAS CONTEMPLATING THE BEST APPROACH FOR THE LEAD REVISION AND OFF-LABEL USE WAS DISCUSSED. IT WAS LATER REPORTED THAT NON-BOSTON SCIENTIFIC LEAD WAS SURGICALLY ABANDONED. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AS WELL AS A SUBPECTORAL POSITION WAS WARRANTED FOR THIS PATIENT. THE DEVICE WAS BEING RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND DETAILED ANALYSIS IS PENDING.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED NOISE ON A NON-BOSTON SCIENTIFIC DEFIBRILLATION LEAD. THIS NOISE RESULTED IN UNNECESSARY SHOCKS. IN ADDITION, PACING IMPEDANCES WERE >2000 OHMS, HOWEVER, THE SHOCKING IMPEDANCES WERE WITHIN RANGE. THERE WAS ALSO AN INCREASE IN THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PATIENT IS NOT DEVICE DEPENDANT.

    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 82 YR 4074| 4548| 1284| H177| 4479| 6949| 4574| N119