BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 701419 · Received April 10, 2006

    Report

    Report Number
    701419
    Event Type
    Malfunction
    Date Received
    April 10, 2006
    Date of Event
    February 20, 2006
    Report Date
    April 7, 2006
    Manufacturer
    METRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT VENTRICLE LEAD REPLACED DUE TO HIGH THRESHOLDS. THE LEAD WAS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACING LEAD DTB METRONIC, INC. 4076-58 BBL058319V

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR