BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2240806 · Received August 28, 2011

    Report

    Report Number
    2240806
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 28, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6949-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR