BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1771259 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12347
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 9, 2010
    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

    THE DEVICE AND LEADS REMAIN IMPLANTED. A BOSTON SCIENTIFIC CRM TECHNICAL CONSULTANT REVIEWED THE SAVE TO DISK AND DISCUSSED THAT THE LEADS DID NOT APPEAR TO BE REVERSED IN THE HEADER. THIS IS BASED ON THE FACT THAT THE SHOCK EGM OF THE COGNIS/TELIGEN IS MEASURED BETWEEN DISTAL COIL AND CAN. IF THE HIGH VOLTAGE LEAD PINS WERE REVERSED, THE SHOCK EGM WOULD BE RECORDED BETWEEN THE SVC AND CAN. WHEN THAT OCCURS, THE SHOCK EGM WOULD SHOW NEGATIVE P WAVES. HOWEVER, TO EXCLUDE ANY HARDWARE ISSUES, IT IS SUGGESTED TO DO AN INVASIVE CHECK OF THE LEADS TO ENSURE PROPER CONNECTIONS. ALSO, MAKE SURE THAT THE POCKET IS WET AND CLOSED BEFORE DFT TESTING. BEFORE OPENING THE PATIENT, SHOCK IMPEDANCE MEASUREMENTS SHOULD BE PERFORMED IN EACH SHOCK VECTOR TO VERIFY IF THE PROXIMAL COIL IS INTACT. THE SHOCK IMPEDANCE FROM DISTAL COIL TO PROXIMAL COIL SHOULD BE CLOSE TO THE SHOCK IMPEDANCE FROM DISTAL COIL TO CAN. IF THERE IS A BIG DIFFERENCE IN SHOCK IMPEDANCE, THE PROXIMAL COIL MIGHT BE DAMAGED. IF NO DEFECTS ARE FOUND AND IT IS IMPOSSIBLE TO TERMINATE A VT/VF WITH THE DEVICE, PERHAPS IT MIGHT BE CONSIDERED TO ADD AN SQ ARRAY FOR THIS PATIENT AND PROGRAM TO A COLD CAN. A REVISION PROCEDURE WAS PERFORMED; WHERE IT WAS CONFIRMED THAT THE LEADS WERE INDEED REVERSED IN THE HEADER. THE LEADS WERE POSITIONED CORRECTLY AND THE SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE REPLACEMENT PROCEDURE, THE PATIENT WAS INDUCED WITH A 50HZ BURST AND THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR CORRECTLY DETECTED AND CHARGED TO 31J; HOWEVER, THE DEVICE FAILED TO DEFIBRILLATE. THE DEVICE THEN RE-DETECTED AND CHARGED TO 41J AND ONCE AGAIN FAILED TO DEFRIBRILLATE. EXTERNAL DEFIBRILLATION AT 360J WAS SUCCESSFUL. THE POLARITY WAS REVERSED FROM THE INITIAL TRIAD AND RE-INDUCED WITH THE SAME METHOD AND OUTCOME. THE SHOCK VECTOR WAS THEN RE-PROGRAMMED TO INITIAL COIL TO CAN AND RE-INDUCED WITH 50HZ WITH THE SAME OUTCOME AND POLARITY. THIS SHOCK VECTOR WAS REVERESED WITH THE SAME INDUCTION METHOD AND OUTCOME. EACH TIME, THE PATIENT WAS SUCCESSFULLY DE-FIBRILLATED WITH AN EXTERNAL SHOCK AT 360J. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO RECOVERY WHERE LEAD CHECKS WERE PERFORMED AS NORMAL, THRESHOLDS AND SENSING WERE NORMAL AS WELL. IT WAS SUSPECTED THAT THE LEADS WERE REVERSED IN THE HEADER. (LEAD MODEL AND SERIAL NUMBERS UNKNOWN). A SAVE TO DISK WAS PERFORMED AND SENT TO A BOSTON SCIENTIFIC CRM TECHNICAL CONSULTANT FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention