BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ELITE II

    MDR report key: 250009 · Received November 17, 1999

    Report

    Report Number
    250009
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    September 29, 1999
    Report Date
    October 6, 1999
    Manufacturer
    MEDTRONIC
    Product Code
    DXY
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD CHRONIC PACER AND LEAD INFECTION FOR SEVERAL MONTHS(YEARS) CAUSING EROSION OF PACER POCKET AND EXPOSING LEAD. ENTIRE SYSTEM REMOVED. SYSTEM CONTINUED TO WORK APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ELITE II Implant PACEMAKER DXY MEDTRONIC ELITE 7086 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R