BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 4140492 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17391
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD AND DEFIBRILLATOR EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. IT WAS NOTED THAT THE PATIENT WAS 100 PERCENT PACED IN THE ATRIUM. THE CAUSE OF THE LOSS OF CAPTURE AND HIGH IMPEDANCE MEASUREMENTS WAS NOT ABLE TO BE DETERMINED. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE DEVICE AND RA LEAD WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618233 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4543| H220| N141| 4470| 4137| 0185