BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC, INC.

    MDR report key: 172375 · Received June 9, 1998

    Report

    Report Number
    MW1013992
    Event Type
    Other
    Date Received
    June 9, 1998
    Date of Event
    March 2, 1998
    Report Date
    June 9, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAD WAS INSERTED INTO THE HEART. THE TIMES EMBEDDED IN THE HEART VALVE AND SEPARATED FROM THE LEAD. THE PHYSICIAN COULD NOT DETERMINE IF THE TIMES SEPARATED FROM THE LEAD AS A RESULT OF THE PROCEDURE OR AS A RESULT OF A PRODUCT DEFECT. 6 TIMES WERE LEFT IN PT. PT WAS INFORMED OF INCIDENT BY PHYSICIAN. TO DATE, NO ADVERSE EFFECT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. Implant LEAD DTB MEDTRONIC, INC. 5034 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other