BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1873925 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17747
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS SENT HOME WITH THE PATIENT, SO CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICD. IT WAS NOTED THAT THE MONITORING VOLTAGE WAS 2.58V AND THE CHARGE TIME WAS 22 SECONDS. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND APPEARED TO HAVE EXHIBITED THE ADVISORY BEHAVIOR BY EXCEEDING THE EXTENDED CHARGE TIME LIMIT OF 18.9 SECONDS.

    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 54 YR Required Intervention 0184| T125| 4469| E110