BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC KAPPA 700 KSR 701

    MDR report key: 304328 · Received October 27, 2000

    Report

    Report Number
    304328
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    April 16, 2000
    Report Date
    September 14, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCUMENTED PACEMAKER FAILURE WITH HEART RATE DROPPING TO 35 PER MINUTE AND NO EVIDENCE OF PACING. MEASURED LEAD IMPEDANCE DROPS TO LESS THAN 100 OHMS WITH MANIPULATION OF PACER POCKET. PT REQUIRED REMOVAL OF OLD PULSED GENERATOR, REMOVAL OF TRANSVENOUS ELECTRODE AND NEW PACING ELECTRODES AND PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC KAPPA 700 KSR 701 PACEMAKER DXY MEDTRONIC, INC. 700 KSR701 *
    2 MEDTRONIC KAPPA 700 KSR 701 LEAD DTB MEDTRONIC, INC. 700 KSR 701 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention