BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173275 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11560
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    January 12, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATIONS AT THIS TIME ARE THAT THE LEAD MAY HAVE MIGRATED A LITTLE, THRESHOLDS HAVING RISEN TO 2.9 AT 1.0. THERE WAS NO ALLEGATION OF A DEVICE TO LEAD CONNECTION ISSUE, HOWEVER THIS DEVICE HAD BEEN IMPLANTED ONE MONTH AT THE TIME OF THE ALLEGATION OF -OUT-OF-RANGE IMPEDANCE. TO DATE, INFORMATION SUGGESTS THAT THIS LV LEAD REMAINS IN SERVICE. AS NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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

    THE DEVICE WAS EXPLANTED AND RETURNED FOLLOWING THE PATIENT'S DEATH. THERE WERE NO ALLEGATIONS RELATING TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THE TRANSVENOUS LEFT VENTRICULAR (LV) LEAD DID EXHIBIT AN INTERMITTENT RISE IN PACE IMPEDANCE TO GREATER THAN 2000 OHMS. AT IMPLANT, THE LEAD IMPEDANCE WAS AT 1000 OHMS AND HAS GRADUALLY RISEN TO OUT OF RANGE. NO OVER SENSING WAS NOTED BUT ALSO THERE HAD BEEN NO PRESENTING ELECTROCARDIOGRAM (EGM) TO LOOK AT. THE PLAN WAS TO BRING THE PATIENT IN FOR TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4457| 1290| N119| 4470| 4542