BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 505512 · Received October 3, 2003

    Report

    Report Number
    MW4003615
    Event Type
    Injury
    Date Received
    October 3, 2003
    Date of Event
    September 16, 2003
    Report Date
    September 25, 2003
    Manufacturer
    ST. JUDE MEDICAL/PACESETTER
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACEMAKER DXY ST. JUDE MEDICAL/PACESETTER 5370 *
    2 ST JUDE MEDICAL LEADS DTB ST JUDE MEDICAL/PACESETTER 1488T *
    3 ST JUDE MEDICAL LEADS DTB ST JUDE MEDICAL/PACESETTER 1488T *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention