BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INC

    MDR report key: 440428 · Received January 29, 2003

    Report

    Report Number
    440428
    Event Type
    Injury
    Date Received
    January 29, 2003
    Date of Event
    December 4, 2002
    Report Date
    January 22, 2003
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED PERMANENT PACEMAKER EOL, DUAL CHAMBER REPLACEMENT. LEADS WERE CHECKED AND NO PROBLEMS FOUND. BATTERY/GENERATOR REPLACEMENT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC PACEMAKER DXY MEDTRONIC INC. KDR701 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R