BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 1850234 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14550
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    July 2, 2010
    Report Date
    November 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED APPROXIMATELY 3 YEARS LATER FOR NORMAL BATTERY DEPLETION. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED. 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 THE LEFT VENTRICULAR TIP SEAL PLUG HAD CUTS AROUND IT AND BODY FLUID CONTAMINATION IN ITS SEAL PLUG CAVITY. NO HOLES WERE NOTED IN ANY OF THE SEAL PLUGS AND ALL OTHER SEAL PLUGS WERE INTACT AND NO OBSTRUCTIONS WERE NOTED IN ANY OF THE LEAD BARRELS. 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, 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 WAS UNABLE TO CONFIRM THE ALLEGATION OF OVERSENSING. THE DEVICE WAS EXPLANTED 3.3 YEARS AFTER THE EVENT OCCURRENCE FOR NORMAL BATTERY DEPLETION AND NO FURTHER OVERSENSING ISSUES WERE REPORTED IN THAT TIME. ANALYSIS CONCLUDED THE DEVICE MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE SUBSEQUENTLY REPORTED THAT DISCUSSIONS WITH THE PATIENT REVEALED THAT THE PACING PAUSE WAS NOT CORRELATED WITH THE REPORTED SYNCOPE. PROGRAMMING CHANGES WERE MADE TO SET SENSITIVITY TO LEAST, DECREASE THE ATRIO-VENTRICULAR DELAY, AND SLIGHTLY INCREASE THE PACING LOWER RATE LIMIT. THE PATIENT WILL BE MONITORED TO REVIEW THE EFFECT OF THE PROGRAMMING CHANGES. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS ASSOCIATED WITH A REPORT OF OVERSENSING THAT RESULTED IN PACING INHIBITION AND PATIENT SYNCOPE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT LEAD MEASUREMENTS WERE GOOD AND THERE WAS NO EVIDENCE OF LEAD NOISE. THE REPRESENTATIVE SAW A MARKED ATRIAL SENSE ON TELEMETRY THAT WAS NOT FOLLOWED BY A RIGHT VENTRICULAR PACING SPIKE OR INTRINSIC MARKER. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED POSSIBLE CAUSES AND TROUBLESHOOTING RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H225

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4518| H225| 0185