BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1954225 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24709
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    February 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THERE WAS NO EVIDENCE OF CROSS-THREADED SETSCREWS. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT THE 1.1 JOULES COMMANDED SHOCKS AT IMPLANT RESULTED IN HIGH SHOCK IMPEDANCE MEASUREMENTS OF 98 AND 81 OHMS SHOCK IMPEDANCE. THE FOLLOWING 26 JOULES AND 41 JOULES SHOCKS RESULTED IN GREATER THAN 125 OHMS MEASUREMENTS. THE RV, LV, AND ATRIAL IMPEDANCE MEASUREMENTS WERE NORMAL. 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

    TO DATE, INFORMATION SUGGESTS THAT THIS ATTEMPTED MEDICAL DEVICE AND THE CHRONIC MEDICAL DEVICE WERE REMOVED FROM SERVICE AND TO BE RETURNED TO BOSTON SCIENTIFIC. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL RE-EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILATOR (CRT-D) IN ASSOCIATION WITH THE NON-BSC DEFIBRILLATION LEAD DID EXHIBIT OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT IN ALL SHOCK VECTORS. DURING THE IMPLANT TESTING, LOW ENERGY SHOCKS REMAINED WITHIN NORMAL LIMITS. PAZCE/SENSE MEASUREMENTS WERE ALSO WITHIN NORMAL LIMITS. THE PHYSICIAN PLANNED TO CONDUCT HIGH ENERGY SHOCK TO TEST THE DEVICE SYSTEM INTEGRITY. IT WAS NOTED THAT THE LEAD CONDUCTORS APPEARED INTACT. THE PHYSICIAN CHECKED ALL THE DEVICE TO LEAD CONNECTIONS BY PULLING THE LEADS OUT AND RE-INSERTING, YET STILL THERE REMAINED GREATER THAN 125 OHMS SHOCK IMPEDANCE. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT ASKED IF THE PINS WERE VISIBLE BEYOND THE CONNECTOR BLOCK BUT THERE WAS NO CONFIRMATION OF THIS FROM THE LOCAL AREA SALES REPRESENTATIVE. THE PHYSICIAN ELECTED TO TEST THE CHRONIC CRT-D AND HAD THE SAME OUTCOMES. NO ADVERSE PATIENT EFFECT WAS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)