BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL CARDIAC PACEMAKER

    MDR report key: 3872187 · Received June 10, 2014

    Report

    Report Number
    MW5036561
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 11, 2014
    Report Date
    May 24, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE WALKING ON A 3 MILE WALK ACROSS THE ANNUAL BRIDGE WALK TO (B)(6), WHICH I TRY AND DO EVERY YEAR WITH NO PROBLEMS, I WAS HAVING A HARD TIME BREATHING AND STARTING TO BECOME DIZZY. I TOOK MY PULSE AND IT STAYED AT 75 WHEN BY THIS TIME IT SHOULD BE AT LEAST 90 TO 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338455 ST. JUDE MEDICAL CARDIAC PACEMAKER ST. JUDE MEDICAL CARDIAC PACEMAKER NVZ ST. JUDE MEDICAL P/G 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention THYROID TAB 100MCG ONE A DAY| COREG ER 80 MG ONE A DAY| MICARDIS 40 MG ONE A DAY| MULTI VITS| ASA 80 ONE A DAY