BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 347664 · Received August 13, 2001

    Report

    Report Number
    347664
    Event Type
    Injury
    Date Received
    August 13, 2001
    Date of Event
    June 27, 2001
    Report Date
    August 1, 2001
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSULATION BREAK. INTERMITTENT LOSS OF CAPTURE ON V-LEAD DUE TO LEAD DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36472 MEDTRONIC DUAL CHAMBER PACEMAKER DTB MEDTRONIC INC. 5034-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention