BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1875037 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18532
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 9, 2009
    Report Date
    March 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INH-LVP MARKERS ON THE PRINTED ELECTROGRAMS. IT WAS QUESTIONED WHAT THIS MARKER MEANT. TECHNICAL SERVICES (TS) DISCUSSED THEY SUSPECTED FARFIELD P WAVE OVERSENSING ON THE LEFT VENTRICULAR (LV) CHANNEL, EXHIBITED BY A NON-BOSTON SCIENTIFIC LV LEAD. THE LV CONFIGURATION WAS REPROGRAMMED, WHICH WAS NOTED TO HAVE RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE INH-LV MARKERS WERE AGAIN OBSERVED ON LATITUDE PRESENTING ELECTROGRAMS. TS REVIEWED THE PRESENTING ELECTROGRAM, AND NOTED THERE MAY NOT BE OVERSENSING, THAT THEY WERE UNSURE IF THE RIGHT VENTRICULAR (RV) PACE WAS CAPTURING OR FUSING, ALSO EXHIBITED BY A NON-BOSTON SCIENTIFIC RV LEAD. TS SUGGESTED THEY ASSESS WITH A SURFACE ELECTROCARDIOGRAM, AND SUGGESTED SOME TROUBLESHOOTING AND PROGRAMMING OPTIONS. IT WAS NOTED THIS WOULD BE RE-ASSESSED WHEN THE PATIENT RETURNED FOR THEIR NEXT DEVICE CHECK. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT IT WAS QUESTIONED IF THE FACT THAT LV SENSING HAD BEEN PROGRAMMED OFF WOULD HAVE CAUSED THE LV ELECTROGRAMS TO APPEAR FLAT. TS CONFIRMED THAT LV SENSING BEING PROGRAMMED OFF WOULD CAUSE THIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LV PACING PERCENTAGE WAS AGAIN QUESTIONED. IT WAS NOTED THAT THE PATIENT HAD CORONARY STENTS PLACED. TS DISCUSSED THAT IT WAS POSSIBLE THAT THE STENT PLACEMENT MAY HAVE CAUSED THE LV LEAD TO MOVE, THUS NOW PICKING UP ATRIAL ACTIVITY. TS AGAIN DISCUSSED PROGRAMMING OPTIONS. IT WAS NOTED THAT AN X-RAY WOULD BE PERFORMED TO DETERMINE A POSSIBLE LEAD DISLODGEMENT.

    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 81 YR S602| 4469| 6947| 4194| N119