BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1620087 · Received February 23, 2010

    Report

    Report Number
    1620087
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 23, 2010
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    AN INDWELLING RIGHT VENTRICULAR DEFIBRILLATOR LEAD DEVELOPED A FRACTURE WHICH NECESSITATED ITS REMOVAL AND REPLACMENT WITH A NEW LEAD. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY. MANUFACTURER RESPONSE (AS PER REPORTER) FOR RIGHT VENTRICULAR DEFIBRILLATOR LEAD, FIDELISNONE KNOWN.

    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 66 YR Hospitalization| R OSE WHILE PATIENT DOING NORMAL ACTIVITIES OF DAILY| LIVING| NONE KNOWN - IT WAS IMPLANTED DEVICE - PROBLEMS AR