BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 304382 · Received October 27, 2000

    Report

    Report Number
    MW4002851
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    September 19, 2000
    Report Date
    October 13, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURED LEAD CAUSED RECURRENT DEFIBRILLATOR DISCHARGES. OLD LEAD REMOVED, NEW LEAD POSITIONED. ONLY PT ADVERSE OUTCOME TRIP TO CATHETERIZATION LAB AND DISCOMFORT OF UNNECESSARY SHOCKS. LEAD NOT THAT OLD. HARD TO SEE HOW IT WOULD FRACTURE THIS EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. VENTRICULAR LEAD LWS MEDTRONIC, INC. 6945-45 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention