BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951622 · Received January 6, 2011

    Report

    Report Number
    2124215-2011-00289
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE RV TIP SEAL PLUG WAS DAMAGED; ALL OTHER SEAL PLUGS WERE INTACT. WHILE THE DEVICE HEADER WAS CONFIRMED TO BE LOOSE, IT REMAINED ATTACHED TO THE DEVICE CASE. COMPOSITIONAL ANALYSIS COMPLETED ON TWO SAMPLE AREAS WHERE THE HEADER WAS LOOSE FROM THE DEVICE CASE VERIFIED A UNIFORM LAYER OF MEDICAL ADHESIVE ON THE HEADER AND VERY LITTLE MEDICAL ADHESIVE ON THE TITANIUM CASE. THE CONTAMINATION OBSERVED IN THE FIELD DID NOT APPEAR TO BE CAUSED BY THE LOOSE HEADER, BUT WAS LIKELY DUE TO BLOOD INFILTRATION THROUGH THE DAMAGED SEAL PLUG. PIN GAUGE TESTING WAS PERFORMED ON THE ALL PORTS, WITH NORMAL RESULTS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. MANUAL IMPEDANCE TESTING PRODUCED MEASUREMENTS THAT WERE WITHIN NORMAL RANGE. PACING AND SHOCK THERAPY REMAINED AVAILABLE. THE HIGH RV PACING IMPEDANCE ISSUE THAT WAS OBSERVED COULD NOT BE CONFIRMED WITH LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION PROCEDURE FOR THE RIGHT VENTRICULAR COMPETITOR LEAD THAT HAD A GRADUAL INCREASE IN IMPEDANCES UP TO GREATER THAN 2,000 OHMS; THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR WAS NOTED TO HAVE A 'BREAK' AT THE CONNECTION FILLED WITH BLOOD. IN ADDITION, THE DEVICE HEADER WAS LOOSE AND FILLED WITH BLOOD. THE LEFT VENTRICULAR AND ATRIAL LEAD MEASUREMENTS WERE WITHIN NORMAL MEASUREMENTS AND THE LEAD REMAINED IMPLANTED. DIFFICULTY WAS EXPERIENCED WHEN EXTRACING THE DEVICE OUT OF THE POCKET FROM UNDER THE MUSCLE. THE DEVICE HAD BEEN IMPLANTED WITH THE LABEL FACING UP. THE DEVICE WAS EVENTUALLY REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL 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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other