BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013432 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00908
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    November 6, 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
    NY
    Reporter Occupation
    INVALID DATA

    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 75 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR