BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 607633 · Received January 25, 2005

    Report

    Report Number
    607633
    Event Type
    Injury
    Date Received
    January 25, 2005
    Date of Event
    January 21, 2005
    Report Date
    January 25, 2005
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SEEN FOR ROUTINE PACEMAKER F/U AND NOTED TO HAVE LARGE INCREASE IN VENTRICULAR CAPTURE THRESHOLD. PACEMAKER PROGRAMMED TO MAXIMUM OUTPUT AND PT WAS HOSPITALIZED UNTIL VENT LEAD COULD BE REPLACED. 1/25/2005 - VENTRICULAR LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR PACING LEAD DTB MEDTRONIC 5076 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R