BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2082280 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08126
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    February 3, 2011
    Report Date
    August 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THE LOCAL AREA SALES REPRESENTATIVE INQUIRED REGARDING DEVICE PROGRAMMING AND NOISE MARKERS WHICH WERE CONFIRMED BY TECHNICAL SERVICES AS NORMAL OPERATION. THE LOCAL AREA SALES REPRESENTATIVE ALSO MENTIONED THAT THE SAME OUT-OF-RANGE IMPEDANCE ISSUE PREVIOUSLY REPORTED WAS STILL OCCURRING. NO INTERVENTION WAS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THE TRANSVENOUS RIGHT ATRIAL (RA) LEAD DID EXHIBIT GREATER THAN 2,000 OHMS PACE IMPEDANCE. ALL OTHER MEASUREMENTS APPEARED TO BE WITHIN NORMAL LIMITS. THE PATIENT WAS NOTED AS HAVING INTERMITTENT ATRIAL FIBRILLATION. WITH POCKET MANIPULATION, THE PHYSICIAN NOTED THAT PACE IMPEDANCE WAS AT 1,000 OHMS, WITH P WAVE AND PACING THRESHOLD REMAINING THE SAME. THE BOSTON SCIENTIFIC LOCAL AREA SALE REPRESENTATIVE THOUGHT THERE MAY BE A DEVICE TO LEAD CONNECTION INVOLVED, SUCH AS A SET SCREW OR POSSIBLY LEAD INSERTION ISSUE. THE PHYSICIAN OPTED NOT TO PERFORM A CHEST X-RAY OF THE DEVICE HEADER OR REVISE THE SYSTEM. THE SYSTEM WAS TO BE MONITORED EXTERNALLY UNTIL SUCH TIME AS THE SENSING OR PACING WOULD BEGIN TO HAVE ISSUES.

    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 82 YR 4470| 4543| 0185| N119