BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3052742 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05592
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED SCRATCHES ON THE CASE AND MINOR BODY FLUID CONTAMINATION IN THE LEAD BARRELS. THE HEADER WAS OBSERVED TO BE FIRMLY ATTACHED TO THE DEVICE CASING. 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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD WERE SUCCESSFULLY EXPLANTED AND REPLACED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND MULTIPLE SHOCKS. THE NOISE WAS ABLE TO BE REPRODUCED WITH MANIPULATION OF THE DEVICE HEADER. THE LOCAL FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND INQUIRED ABOUT ADVISORY STATUS OF THE DEVICE. TS DISCUSSED THAT THIS DEVICE IS INCLUDED IN THE (B)(6) 2009 SUBPECTORAL IMPLANT 2009 ADVISORY POPULATION. THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE DEVICE WAS NOT IMPLANTED SUBPECTORAL. AN INVASIVE PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND A FRACTURE WAS OBSERVED IN THE LEAD. NOISE WAS PRODUCED WHEN THE LEAD WAS MANIPULATED NEAR THE FRACTURE AND ALSO NEAR THE DEVICE HEADER. A HEADER ISSUE WAS UNABLE TO BE RULED OUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156345 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4474| N119| 4195| 4549| 0185