BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 118803 · Received September 11, 1997

    Report

    Report Number
    118803
    Event Type
    Injury
    Date Received
    September 11, 1997
    Date of Event
    July 2, 1997
    Report Date
    July 14, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED PACEMAKER LEAD. A NEW LEAD AND NEW GENERATOR INSERTED. FAILED LEAD WAS LEFT IN PT AND CAPPED OFF. OLD GENERATOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. Implant PACEMAKER LEAD DTB MEDTRONIC, INC. 4004M-52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention