BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 538827 · Received August 10, 2004

    Report

    Report Number
    538827
    Event Type
    Other
    Date Received
    August 10, 2004
    Date of Event
    June 7, 2004
    Report Date
    August 6, 2004
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER DEFIBRILLATOR LEAD WAS PLACED VIA SUBCLAVIAN ACCESS, THE PT WAS NOTED TO BE HYPOXIC. STAT CHEST X-RAY REVEALED A LEFT SIDED PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR LEAD LWS MEDTRONIC, INC. 6974 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other