BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2041792 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01240
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THAT THE LV- SEAL PLUG WAS TORN AND BODY FLUID CONTAMINATED ITS CONNECTOR BLOCK. NO OTHER ANOMALIES WERE NOTED. 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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS TESTING COULD NOT CONFIRM THE REPORTED ALLEGATIONS.

    Additional Manufacturer Narrative · 1

    AS A RESULT THE LEAD AND DEVICE WERE EXPLANTED. THERE WAS ALLEGATION THAT THE BATTERY IN THE DEVICE WAS DRAINED DUE TO THE ISSUES WITH THE DEFIBRILLATION LEAD. A RETURN REQUEST WAS MADE FOR THE RETURN OF THESE PRODUCTS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED NOISE, UNDERSENSING, A LOSS OF CAPTURE AND PACING IMPEDANCES LESS THAN 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PATIENT HAD NOT BEEN EVALUATED FOR OVER A YEAR.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 4543| H227| 4087| 0185