BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3041117 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00666
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE HEADER AND LEAD BARRELS NOTED BODY FLUID CONTAMINATION THROUGHOUT EACH OF THE LEAD BARRELS. IN ADDITION, THERE WAS A HOLE IN THE RIGHT VENTRICULAR TIP SEAL PLUG. SEAL RING MARKS IN THE DF-1 LEAD BARREL INDICATED THAT THE LEAD MAY HAVE BEEN UNDERINSERTED. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS CONCLUDED THIS DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED. DURING A FOLLOW UP VISIT, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. A REVISION PROCEDURE WAS PERFORMED. AFTER THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED, SHOCK IMPEDANCE MEASUREMENTS REMAINED VARIABLE. A DECISION WAS MADE TO ALSO REPLACE THIS DEVICE. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144085 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R