BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 2153587 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-08071
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE DEVICE WAS INTERROGATED AND THE LEAD IMPEDANCE WAS NOTED. THE RV LEAD WAS REPORTEDLY FRACTURED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SUCCESSFULLY EXTRACTED AND REPLACED. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR A135| 4470| 0158| H220| 4542| 4548