BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2060016 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05797
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    November 30, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD WAS SUCCESSFULLY REPLACED, AND WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, INFORMATION WAS RECEIVED THAT THIS ICD WAS DISCARDED AT THE HOSPITAL, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS INTERROGATED AND FOUND TO HAVE A BATTERY STATUS OF MIDDLE OF LIFE 2. REVIEW OF DEVICE MEMORY CONFIRMED THE REPORTED LONG CHARGE TIME; HOWEVER, CHARGE TIMES REMAINED BELOW THAT WHICH WILL TRIGGER A BATTERY STATUS OF ERI. EXTENDED CHARGE TIMES DURING MID-LIFE IS NORMAL DEVICE FUNCTION. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS. THE DEVICE PASSED ALL TESTS AND FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CHARGE TIMES THAT WERE LONGER THAN EXPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) WAS CONTACTED REGARDING A LONGEVITY CALCULATION, AND ADVISORY INFORMATION. ADDITIONAL INFORMATION WAS JUST RECEIVED THAT THE DECISION WAS MADE TO EXPLANT THIS DEVICE. THIS ICD WAS IN MIDDLE OF LIFE 2 (MOL 2). NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 1870| 0158