BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2052157 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03551
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 6, 2012
    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. THE PATIENT HAD BEEN SCHEDULED FOR ROUTINE FOLLOW-UP THREE MONTHS OUT. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THIRTEEN MONTHS LATER, THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    -----

    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 MARCH 2009 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON 4/5/2007, REACHED A MONITORING VOLTAGE MEASUREMENT OF 2.58 VOLTS AND A CHARGE TIME MEASUREMENT OF GREATER THAN 18 SECONDS. THE PATIENT WAS NOT BEING COMPLIANT ABOUT FOLLOW-UP. THERE WAS CONCERN THAT THE BATTERY WAS DEPLETING EARLIER THAN EXPECTED DUE TO EXTENDED CHARGE TIME. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R T180| 0185| 4086