BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1072294 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03298
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 19, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. 4568 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention H115 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 4512 IMPLANTABLE PACING LEAD| 0147 IMPLANTABLE TACHY LEAD