BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 3212494 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09436
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL OBSERVATION NOTED THAT A WRENCH WAS STUCK IN THE LEFT VENTRICULAR (LV) TIP SET SCREW. THE WRENCH WAS OBSERVED TO BE BROKEN OFF FLUSH WITH THE TOP OF THE SET SCREW (IN THE UP POSITION). LABORATORY ANALYSIS CONCLUDED THAT ANOTHER MANUFACTURER'S WRENCH WAS USED TO LOOSEN THE SET SCREW. THE LV TIP SEAL PLUG WAS REMOVED AND THE WRENCH TIP WAS REMOVED FROM THE SET SCREW. 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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN INAPPROPRIATE SHOCKS. THE LEAD WAS OBSERVED TO HAVE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. WHEN THE SET SCREWS WERE LOOSENED ON THE DEVICE HEADER TO REMOVE THE LEAD, WRENCHES KEPT BREAKING OFF IN THE SET SCREWS AND A PART OF A WRENCH BECAME STUCK IN THE SET SCREWS AND COULD NOT BE REMOVED. THE DEVICE WAS THEN EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313042 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0181| 4517| H229