BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC KAPPA KSR 401 GENERATOR

    MDR report key: 374824 · Received January 30, 2002

    Report

    Report Number
    MW1023972
    Event Type
    Injury
    Date Received
    January 30, 2002
    Date of Event
    August 8, 2001
    Report Date
    January 23, 2002
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH A PERMANENT PACEMAKER IMPLANTED IN 1999 CALLED THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF DYSPNEA WITH EXERTION AND FATIGUE. INITIALLY, UPON WALK RATE THE PT HAD ACHIEVED MAXIMUM HEART RATE. AFTER MULTIPLE ATTEMPTS OF REPROGRAMMING, THE PHYSICIAN WAS UNABLE TO SUSTAIN AN ADEQUATE WALK RATE FOR THIS PT DESPITE COMBINED SENSOR CAPABILITY OF THE PACEMAKER. PT UNDERWENT PACEMAKER CHANGE OUT IN 2001 WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC KAPPA KSR 401 GENERATOR IMPLANTABLE GENERATOR DXY MEDTRONIC INC. KSR 401 GENERATOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention GUIDANT PULSAR MAX II SR 1181 GENERATOR.