BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1353091 · Received March 27, 2009

    Report

    Report Number
    MW5010499
    Event Type
    Injury
    Date Received
    March 27, 2009
    Date of Event
    February 20, 2009
    Report Date
    March 27, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PACEMAKER INSERTED IN 2009. FOUR DAYS LATER, RETURNED TO LAB AS LEAD NOT WORKING. LEAD DISCONTINUED. ON THE NEXT DAY, PACEMAKER AGAIN MALFUNCTIONED AND GENERATOR REPLACED. PACEMAKER STILL NOT FUNCTIONING SO, IT WAS EXPLANTED TWO DAYS LATER, AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL PACEMAKER DXY ST. JUDE MEDICAL 5826
    2 ST. JUDE MEDICAL ATRIAL LEAD DTB ST. JUDE MEDICAL 1888
    3 ST. JUDE MEDICAL VENTRICULAR LEAD DTB ST. JUDE MEDICAL 1646T

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention