BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1875117 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19101
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED AN APPROPRIATE LATITUDE RED ALERT FOR HIGH RV PACE IMPEDANCE MEASUREMENT VALUE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION. AT MOST RECENT OFFICE FOLLOW-UP, THE RV PACE IMPEDANCE WAS AROUND 1600 OHMS AND STABLE. THE >2000 OHMS PACE IMPEDANCE MEASUREMENT COULD NOT BE REPRODUCED. THE FOLLOWING PHYSICIAN CHOSE TO MONITOR ONLY FOR THE TIME BEING.

    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 68 YR (B)(4)| (B)(4)| MISMATCH| (B)(4)