BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 3905572 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12795
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RV LEAD AND THE SECOND DEVICE REMAIN IN SERVICE. THE ATTEMPTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. 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. LABORATORY ANALYSIS WAS NOT ABLE TO CONFIRM THE LEAD INSERTION DIFFICULTY THAT WAS OBSERVED CLINICALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER (PSA) AND GOOD IMPEDANCE MEASUREMENTS WERE OBSERVED. WHEN THE LEAD WAS CONNECTED TO THIS DEVICE, THE PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 3,000 OHMS AND THE SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 200 OHMS. THE CONNECTIONS APPEARED TO BE CORRECT. THIS DEVICE WAS REMOVED AND ANOTHER DEVICE OF THE SAME MODEL WAS USED. SIMILAR IMPEDANCE ISSUES WERE OBSERVED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED DETAILED STEPS FOR ENSURING THE LEAD TERMINAL PIN WAS FULLY INSERTED INTO THE DEVICE PORT. AFTER SEVERAL ATTEMPTS, THE RV LEAD WAS PROPERLY CONNECTED TO THE SECOND DEVICE. LEAD MEASUREMENTS WERE ALL WITHIN NORMAL RANGE AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384434 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 G179| 0692