BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 1790355 · Received April 7, 2010

    Report

    Report Number
    1790355
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 6, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED HIS DEVICE STARTED ALARMING. CARELINK CHECK DONE PER PHONE. MEDTRONIC RECOMMENDED PT TO COME TO HOSPITAL TO HAVE DEVICE INTERROGATED. PT LEFT (B)(6) TO COME TO (B)(6) AS RECOMMENDED. MEDTRONIC THEN RECOMMENDED THE DEVICE TO BE PLACED. PT EXPIRED ENROUTE TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS MEDTRONIC, INC. D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death