BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT

    MDR report key: 548335 · Received October 8, 2004

    Report

    Report Number
    548335
    Event Type
    Injury
    Date Received
    October 8, 2004
    Date of Event
    September 15, 2004
    Report Date
    October 8, 2004
    Manufacturer
    GUIDANT CORP.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BIPOLAR ATRIAL LEAD IMPEDANCE DROPPED FROM 560-670 OHMS ON PREVIOUS VISITS TO 100-220 OHMS TODAY. OVERSENSING IS NOTED RESULTING IN TRACKING AT UPPER PACEMAKER RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT ATRIAL PACEMAKER LEAD DTB GUIDANT CORP. 4271 *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R