BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1013557 · Received March 10, 2008

    Report

    Report Number
    2647346-2008-00077
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    January 15, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4524 IMPLANTABLE PACING LEAD| 6936 IMPLANTABLE TACHY LEAD| 4058M IMPLANTABLE PACING LEAD