BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 2780124 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12791
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    July 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING A LEAD REVISION PROCEDURE WAS PERFORMED AND THE RV AND RA LEADS WERE EXPLANTED AND REPLACED. ADDITIONALLY, THIS DEVICE WAS ELECTIVELY EXPLANTED DURING THE LEAD REVISION PROCEDURE. THE DEVICE WAS NOT RETURNED FOR TESTING AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS CONFIRMED TO HAVE HIGH RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS AFTER AN ATTEMPTED ELECTIVE EXPLANT PROCEDURE, AT WHICH TIME THE RA AND RV RING SETSCREWS WERE MOST LIKELY OVER-TORQUED IN THE COUNTERCLOCKWISE DIRECTION AND THEN STUCK IN THE UP POSITION. THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE MEASUREMENTS HAVE BEEN GREATER THAN 2000 OHMS FOR AT LEAST ONE YEAR. THE DEVICE LV CIRCUITRY WAS TESTED AND PASSED ALL TESTING INDICATING THAT THE OUT OF RANGE LEAD IMPEDANCES WERE DUE TO A LEAD RELATED ISSUE. BOTH THE RA AND RV RING SETSCREWS WERE STUCK IN THE UP/LOOSENED POSITION WITH THE RETAINER WASHERS VOLCANOED UP INDICATING OVER-TORQUING IN THE COUNTER CLOCKWISE DIRECTION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE PROCEDURE TO REPLACE THIS DEVICE, THE ASSOCIATED RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS COULD NOT BE REMOVED FROM THE DEVICE HEADER DUE TO STUCK SETSCREWS. MULTIPLE EFFORTS WERE PERFORMED TO REMOVE THE LEADS FROM THE HEADER BUT THEY WERE UNSUCCESSFUL. ADDITIONALLY, THE ASSOCIATED LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS DESPITE GOOD THRESHOLD AND SENSING MEASUREMENTS. THE SYSTEM REMAINS IMPLANTED AND A SECOND ATTEMPT TO REVISE THIS SYSTEM WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 60 YR Hospitalization H227| 4542| 0184| 4135| N161