BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1072141 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03868
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    May 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD| 6942 IMPLANTABLE TACHY LEAD