BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3003786 · Received March 12, 2013

    Report

    Report Number
    3003786
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURED SPRINT FIDELIS RV ICD LEAD. PATIENT WAS FOUND TO HAVE A FRACTURE OF THE LEFT (SUB-PULMONARY) VENTRICLE LEAD. LEADS AND ICD SENT BACK TO MANUFACTURER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXPLANT ICD AND LEADS AND RE-IMPLANT NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103479 SPRINT FIDELIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR