BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1037977 · Received May 2, 2008

    Report

    Report Number
    MW5006652
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 2, 2008
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BATTERY DRAIN MUCH SOONER THAN EXPECTED ERI PT SEEN IN 08. ESTIMATED LONGEVITY 1 YR ON PREVIOUS DEVICE CHECK IN 2007. EXPECTED TOTAL LONGEVITY 9 YRS. ACTUAL 4 YRS 7 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL 5380 IDENTITY / ADX DR DXY 1688 TC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR