BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 506550 · Received January 15, 2004

    Report

    Report Number
    506550
    Event Type
    Injury
    Date Received
    January 15, 2004
    Date of Event
    August 19, 2003
    Report Date
    December 3, 2003
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO'S DATA ON THE BATTERY PERFORMANCE OF THE ST. JUDE MEDICAL TRILOGY FAMILY OF PACEMAKERS REVEALS UNANTICIPATED PRECIPITOUS BATTERY DEPLETION. ADVERSE OUTCOMES HAVE BEEN DEMONSTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PERMANENT PACEMAKER DXY ST JUDE MEDICAL 2364L *
    2 ST JUDE MEDICAL PERMANENT PACEMAKER DXY ST JUDE MEDICAL 2360L *
    3 ST JUDE MEDICAL PERMANENT PACEMAKER DXY ST JUDE MEDICAL 2260L *
    4 ST JUDE MEDICAL PERMANENT PACEMAKER DXY ST JUDE MEDICAL 2264L *
    5 ST JUDE MEDICAL PERMANENT PACEMAKER DXY ST JUDE MEDICAL 2308 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R