BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4884625 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-08236
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 10, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED HIGH OUT-OF-RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT ABRUPT CHANGES TYPICALLY INDICATE A LEAD ISSUE. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429223 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N107

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4316| N107| 4087