BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 783894 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-17755
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    August 23, 2006
    Report Date
    August 23, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE MONITORING VOLTAGE WAS 2.66V AND THE CHARGE TIME WAS 28.9 SEC. THIS DEVICE IS PART OF THE AVT LATCHING POPULATION ADVISORY (6/17/2005). THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention