BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1875172 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18410
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THE COMPETITIVE RV LEAD WAS REVISED, AND THE ICD WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AT THAT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THESE OBSERVATIONS. A REQUEST HAS BEEN MADE TO HAVE THIS EXPLANTED DEVICE RETURNED FOR ANALYSIS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITIVE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE DETECTING NOISE, WHICH RESULTED IN INAPPROPRIATE SHOCKS. THE DEVICE WAS REPROGRAMMED TO MONITOR ONLY MODE UNTIL A COMPETITIVE LEAD REVISION COULD BE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)