BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SECURE

    MDR report key: 1072641 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03479
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    October 2, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB