BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1151194 · Received August 12, 2008

    Report

    Report Number
    1151194
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    August 4, 2008
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MGMT.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC VENTRICULAR LEAD WAS IMPLANTED IN 2007. THE VENTRICULAR LEAD FRACTURED LESS THAN A YEAR LATER AND WAS EXPLANTED. THIS SPRINT FIDELIS LEAD HAS BEEN RECALLED BY MEDTRONIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR