BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1072403 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03651
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    January 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWP
    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 ATTAIN OTW IMPLANTABLE PACING LEAD LWP MEDTRONIC PUERTO RICO, INC. 4193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB