BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INC

    MDR report key: 481761 · Received September 4, 2003

    Report

    Report Number
    481761
    Event Type
    Injury
    Date Received
    September 4, 2003
    Date of Event
    July 26, 2003
    Report Date
    September 4, 2003
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH SEVERAL WEEKS OF MALAISE, FOUND TO HAVE A COMPLETELY DYSFUNCTIONAL PACEMAKER, WITH A NATIVE RHYTHM OF VENTRICULAR ESCAPE AT A RATE OF APPROX 40 BEATS PER MINUTE. THERE WAS LIMITED NON-FUNCTIONAL PACEMAKER ACTIVITY. AFTER CONSIDERING RISKS, BENEFITS AND ALTERNATIVES PT AGREED TO SURGICAL INTERVENTION. PROCEDURE PERFORM: PACEMAKER GENERATOR CHANGE. SURGERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC PACEMAKER DXY MEDTRONIC, INC 7860 29-9966864

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention