BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1010517 · Received February 7, 2008

    Report

    Report Number
    1010517
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 7, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    DUE TO THE PATIENT'S PAST HISTORY OF A HEART BLOCK AND PACER DEPENDENCY THE PHYSICIAN REPLACED THE RECALLED LEAD.====================== MANUFACTURER RESPONSE FOR LEAD, ICD, SPRINT FIDELIS======================KNOWN RECALL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD LWS MEDTRONIC INC. LFJ159302V *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR CARDIAC DRUGS| CARDIAC DRUGS