BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 1072413 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00324
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    August 17, 2007
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SSR303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention