BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951484 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23065
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS NEWLY-IMPLANTED DEVICE AND RIGHT VENTRICULAR (RV) LEAD WERE ASSOCIATED WITH A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT DURING THE NEXT-DAY DEVICE CHECK. POST-IMPLANT IMPEDANCE MEASUREMENTS WERE NORMAL, AND DEFIBRILLATION THRESHOLD TESTING (DFT) WAS SUCCESSFUL AND HAD PRODUCED A NORMAL SHOCK IMPEDANCE MEASUREMENT. VECTOR TESTING ISOLATED THE ISSUE TO THE LEAD'S DISTAL COIL. THE DEVICE POCKET WAS REOPENED, AND THE LEAD'S DISTAL PIN PULLED FREE WHEN TUGGED; VISUAL EXAMINATION CONFIRMED THE DEVICE SETSCREWS WERE EXTENDED. THE SETSCREWS WERE RETRACTED AND THE LEAD RE-INSERTED AND SUCCESSFULLY CONNECTED. 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 N119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4136| N119| 0158| 4968