BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRING FIDELIS

    MDR report key: 1055487 · Received May 31, 2008

    Report

    Report Number
    MW5007091
    Event Type
    Injury
    Date Received
    May 31, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 31, 2008
    Manufacturer
    METRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A RIGHT MEDTRONIC ICD WITH THE SPRINT FIDELIS LEAD. THE LEAD FRACTURED PREMATURELY, TRIGGERING INAPPROPRIATE ICD SHOCKS. PATIENT RECEIVED LEAD REVISION AND HAD POST OP BLEEDING WHICH REQUIRED A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING FIDELIS ICD LEAD LWS METRONIC, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L