BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2041184 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00695
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    October 18, 2010
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE LV LEAD AND CRT-D WERE SUCCESSFULLY IMPLANTED AND REMAIN IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANTATION OF A LEFT VENTRICULAR (LV) LEAD, IT WAS DISCOVERED THAT THE PACING IMPEDANCE MEASUREMENTS WERE ABOVE 2,000 OHMS AFTER IT WAS CONNECTED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD WAS DISCONNECTED FROM THE DEVICE AND THEN RECONNECTED, MAKING SURE THAT THE TERMINAL PIN WAS VISIBLE THROUGH THE CONNECTOR BLOCK. HOWEVER, THE IMPEDANCE MEASUREMENT WAS STILL OUT OF RANGE. THE LV LEAD WAS AGAIN DISCONNECTED FROM THE DEVICE AND TESTED ON THE PACING SYSTEM ANALYZER (PSA), WHICH REVEALED NORMAL IMPEDANCE MEASUREMENTS. THE LV PORT OF THE CRT-D WAS FLUSHED WITH SALINE AND THE LV LEAD WAS AGAIN RECONNECTED. THE PACING IMPEDANCE MEASUREMENT WAS THEN WITHIN NORMAL RANGE. 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 N108

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4592| 0295| N108