BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1871905 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17373
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND COMPETITIVE LEAD REMAIN IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITIVE DEFIBRILLATION LEAD WAS >2000 OHMS. THE LEAD WAS RETESTED ON THE PACING SYSTEM ANALYZER (PSA) AND THE IMPEDANCE WAS 1000 OHMS. THE LEAD WAS THEN REINSERTED INTO THE CRT-D AND THE RV PACING IMPEDANCE WAS 500 OHMS. IT WAS BELIEVED THAT THE IMPEDANCE ISSUE WAS DUE TO THE DIFFICULTY INSERTING AND SECURING THE LEADS INTO THE DEVICE HEADER.

    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