BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 3904834 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10099
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 9, 2013
    Report Date
    October 6, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS COULD NOT CONFIRM THE ALLEGATIONS MADE AGAINST THIS DEVICE IN THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT ATRIAL (RA) LEAD ARE EXHIBITING LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. THE DEVICE WAS PREVIOUSLY TRACKING SOME NOISE BUT THIS HAS SINCE STOPPED AND THERE WERE NO PAUSES OR ASYSTOLE NOTED. THE CRT-D WAS REPROGRAMMED TO VVIR AND THE PATIENT WILL HAVE A RA LEAD REPLACEMENT PROCEDURE SOMETIME IN THE FUTURE. FOR NOW, THE SYSTEM REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE FIELD WAS RECEIVED THAT THE PATIENT'S RA LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A NEW RA LEAD. THE CRT-D CONTINUES TO REMAIN IN SERVICE WITH THE NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION FROM THE FIELD THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION WITH NO FURTHER ALLEGATIONS RELATING TO THIS EVENT BEING MADE AGAINST IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383543 LIVIAN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R H229| 4518| 4136