BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3852928 · Received May 29, 2014

    Report

    Report Number
    3852928
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF RECALLED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316833 SPRINT FIDELIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT), LEAD LWS MEDTRONIC, INC. 6949 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR