BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013426 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00923
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    November 1, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention C174AWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR