BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 442017 · Received February 7, 2003

    Report

    Report Number
    442017
    Event Type
    Injury
    Date Received
    February 7, 2003
    Date of Event
    December 30, 2002
    Report Date
    January 31, 2003
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING INTERMITTENT LOSS OF CAPTURE BECAUSE OF A FRACTURED LEAD (VENTRICULAR). THE LEAD WAS CAPPED & LEFT IN PLACE. ATRIAL LEAD WAS ALSO CAPPED & LEFT IN PLACE BECAUSE INSERTION OF NEW LEADS WAS NOT POSSIBLE ON SAME SIDE. THEREFORE, NEW LEADS WERE INSERTED ON RT SIDE (BOTH ATRIAL & VENTRICULAR LEADS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. ATRIAL & VENTRICULAR LEADS DTB MEDTRONIC, INC. 5034 *
    2 MEDTRONIC, INC. ATRIAL & VENTRICULAR LEADS LWS MEDTRONIC, INC. 5534 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention