BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 1771344 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12432
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    September 17, 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

    IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE. THE DEVICE HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MONITORING VOLTAGE OF 2.56 V AND CHARGE TIME OF 19 SECONDS. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION. THE PATIENT WANTED TO LEAVE ON VACATION. TECHNICAL SERVICES (TS) STATED THAT BECAUSE OF THIS ADVISORY, IT IS UNKNOWN IF CHARGE TIME WILL CONTINUE TO CLIMB. TS DISCUSSED END OF LIVE BEHAVIORS IF CHARGE TIME EXCEEDS 30 SECONDS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention A155| 4472| 0157