BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013891 · Received February 15, 2008

    Report

    Report Number
    1013891
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 8, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE ELECTROPHYSIOLOGY CLINIC FOR A ROUTINE ICD FOLLOW UP. THE PATIENT STATED HE HAD RECEIVED A SHOCK FROM HIS ICD THIS MORNING. THE INTERROGATION OF DEVICE REVEALED A FRACTURED RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD LWS MEDTRONIC INC. 6949-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR