BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3212616 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09365
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED MINOR BODY FLUID CONTAMINATION IN THE LEAD BARRELS AND A SMALL DENT IN THE BACK OF THE DEVICE CASE. ANALYSIS NOTED THAT IMPRESSIONS LEFT BY THE SEAL RINGS OF THE IMPLANTED LEADS INDICATED THAT ALL LEADS WERE FULLY INSERTED INTO THE HEADER, ALL SEAL PLUGS WERE INTACT AND ALL SET SCREWS OPERATED NORMALLY. 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 DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD AND CHRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOSS OF CAPTURE (LOC) RESULTING IN PACING INHIBITION FOR GREATER THAN TWO SECONDS OF ASYSTOLE. THE PATIENT WAS PACEMAKER DEPENDENT. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE. DURING THE REPLACEMENT PROCEDURE, THE LEAD WAS CONNECTED TO A PACING SYSTEM ANALYZER (PSA) AND NORMAL PACING THRESHOLD MEASUREMENTS WERE OBSERVED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED AND THE CHRONIC LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE AND APPROPRIATE CAPTURE WAS OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314465 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 6947| T167| 7274| 0185| 6940| E163