BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3053634 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05336
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 NO ANOMALIES. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE AND LEFT VENTRICULAR (LV) LEAD WERE TAKEN OUT OF SERVICE DUE TO THE CONTINUED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE INTERROGATION, REVIEW OF THE DAILY MEASUREMENTS REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OVER THE LAST TWO MONTHS. IT WAS NOTED THAT THE PATIENT FELT TIRED BUT HAD NO OTHER SYMPTOMS AND ALL OTHER LEAD MEASUREMENTS WERE WITHIN RANGE. THE CLINICIAN PERFORMED ISOMETRICS AND POCKET MANIPULATIONS WITH CONTINUOUS OUT OF RANGE LV IMPEDANCE MEASUREMENTS. SINCE THE LEAD WAS PROGRAMMED LV TIP TO LV RING, OTHER CONFIGURATIONS WERE TESTED. WHEN PROGRAMMED LV TIP TO CAN THERE WAS CONSISTENT IN RANGE IMPEDANCE MEASUREMENTS. SUBSEQUENTLY THE LEAD WAS LEFT PROGRAMMED LV TIP TO CAN AND THEY WILL CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155917 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R H175| N118| 4472| 0184| 4518