BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1013462 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00891
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    October 25, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5068 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5068 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR| 6949 IMPLANTABLE TACHY LEAD| 2187 IMPLANTABLE PACING LEAD| 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR