BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2153563 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06675
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    August 1, 2011
    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

    THE PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR THIS ISSUE VIA LATITUDE AND NORMAL FOLLOW UPS. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ANOTHER HIGH PACING IMPEDANCE MEASUREMENT WAS OBSERVED AND A LOSS OF CAPTURE AS WELL. AS A RESULT THE NON-BOSTON SCIENTIFIC LEAD WAS SURGICALLY ABANDONED AND NEW LEAD WAS SUCCESSFULLY IMPLANTED FOR THE RATE/SENSE FUNCTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED HIGH PACING IMPEDANCES ON A NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR PACE/SENSE LEAD. A REVIEW OF THE PACING IMPEDANCES NOTED TO BE IN THE 400 OHMS RANGE OVER THE PAST FEW MONTHS. 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 N118

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0185| 4470| (B)(4)| H179| 4518| N118