BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1951010 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22936
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE WAS TO BE EXPLANTED IN THE VERY NEAR FUTURE. THIS DEVICE HAS NOT YET RETURNED TO BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. THE INVESTIGATION REMAINS OPEN. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY (B)(6) 2009 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON (B)(6) 2007, DISPLAYED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MONITORING VOLTAGE MEASUREMENT OF 2.49 VOLTS AND A CHARGE TIME MEASUREMENT OF 13.6 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR (B)(4)| (B)(4)