BEUDAMED
    FDA Adverse Event Summary report: N

    ACCENT DR

    MDR report key: 3250772 · Received July 25, 2013

    Report

    Report Number
    3250772
    Date Received
    July 25, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    NVZ
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER GENERATOR REPLACED ABOUT 3 MONTHS AGO. PT HAD EXPERIENCED NEAR SYNCOPAL EPISODES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REVISION OF PACEMAKER LEADS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347358 ACCENT DR ST JUDE PACEMAKER NVZ ST JUDE MEDICAL PM2210 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR