BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY

    MDR report key: 1190218 · Received October 7, 2008

    Report

    Report Number
    MW5008559
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAD A PT IN THE CATH LAB THAT HAD A NEW PERMANENT PACEMAKER DEVICE PLACED, THAT HAD ONE HALF YEAR OF BATTERY LIFE LEFT IN THE BATTERY INSTEAD OF THE 10 YEARS OF LIFE WHICH IS THE AVERAGE. THE BATTERY WAS CHANGED OUT FOR A NEW ONE, AND THE PT HAD NO SEQUELAE. DIAGNOSIS OR REASON FOR USE: COMPLETE HEART BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY VICTORY PACEMAKER DXY ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention