BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2052586 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03698
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    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 END OF LIFE (EOL) DUE TO A CHARGE TIME MEASUREMENT OF 35.3 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THIS DEVICE HAS NOT YET BEEN EXPLANTED. 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 78 YR T175| 0184