BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1616687 · Received February 8, 2010

    Report

    Report Number
    1616687
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 8, 2010
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR LEAD SEEMS TO HAVE FRACTURED. THIS HAS RESULTED IN INAPPROPRIATE ICD DISCHARGE. THE PATIENT UNDERWENT REPLACEMENT OF RIGHT VENTRICULAR (RV) LEAD AND ICD. THE OLD LEAD WAS CAPPED AND LEFT IN PLACE. A NEW DEVICE WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR