BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3021169 · Received March 24, 2013

    Report

    Report Number
    3021169
    Event Type
    Malfunction
    Date Received
    March 24, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ICD AND EXTRACTION OF RIGHT ATRIAL AND VENTRICULAR LEADS DUE TO INFECTION. LEAD TIPS SENT TO PATHOLOGY AND LEAD BODIES SENT TO BIOMED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ICD EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121103 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD LWS MEDTRONIC, INC. 6949-65 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR