BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 473531 · Received July 18, 2003

    Report

    Report Number
    MW1029040
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    July 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PPM KDR701 IMPLANTED WITH 4524-ATRIAL LEAD AND 4024 VENTRICULAR LEAD. PPM PREMATURELY EXPERIENCED BATTERY DEPLETION DUE TO HIGH ATRIAL THRESHOLDS. ATRIAL LEAD WAS ENTIRELY REMOVED DURING PROCEDURE. VENTRICULAR INSULATION WAS DAMAGED DURING GENERATOR REPLACEMENT. VENTRICULAR LEAD WAS THEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. PACEMAKER DXY MEDTRONIC, INC. KDR 701 5NPGU 101844 *
    2 MEDTRONIC, INC. PACEMAKER DTB MEDTRONIC, INC. VENT 4024-52 *
    3 MEDTRONIC, INC. PACEMAKER DTB MEDTRONIC, INC. ATRIAL 4524-45 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention