BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND II

    MDR report key: 1072918 · Received July 10, 2008

    Report

    Report Number
    6000095-2008-00002
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 12, 2008
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND II IMPLANTABLE PULSE GENERATOR DXY VITATRON MEDICAL B.V. 820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention IMX49B X 2 IMPLANTABLE PACING LEADS