BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1061582 · Received June 12, 2008

    Report

    Report Number
    2182208-2008-00153
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 4, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention E2DR01 IMPLANTABLE PULSE GENERATOR