BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4132235 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15146
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 13, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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. 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 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS ATTEMPTED AT IMPLANT. WHEN THE DEVICE WAS CONNECTED TO ANOTHER MANUFACTURER'S LEADS, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. THE SETSCREWS WERE EXAMINED AND CONFIRMED TO BE TIGHT ON THE TERMINAL PINS. ADDITIONALLY, THE ELECTROGRAMS (EGM) WERE COMPLETELY DISASSOCIATED WITH THE PATIENT'S RHYTHM. THE LEADS WERE TESTED VIA A PACING SYSTEM ANALYZER (PSA) AND MEASUREMENTS WERE ACCEPTABLE. THIS DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED WITH ACCEPTABLE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612585 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR MISMATCH| K173