BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1851746 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14175
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY UNDERGOING ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATOR ADVISORY, TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MONITORING VOLTAGE OF 2.57 VOLTS AND CHARGE TIME MEASUREMENTS OF 20.7 SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS ELECTIVELY EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4076| T125| 0185