BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE AFFINITY

    MDR report key: 271072 · Received March 20, 2000

    Report

    Report Number
    MW1018505
    Event Type
    Injury
    Date Received
    March 20, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 17, 2000
    Manufacturer
    ST JUDE MEDICAL, INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INTERNAL PACEMAKER EXPLANTATION AND REPLACED PER ST JUDE ADVISORY (2000) WARNING OF POTENTIAL LOSS OF PACING FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE AFFINITY PACEMAKER INTERNAL DXY ST JUDE MEDICAL, INC 5130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R