BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND II

    MDR report key: 386698 · Received March 8, 2002

    Report

    Report Number
    6000095-2002-00003
    Event Type
    Injury
    Date Received
    March 8, 2002
    Date of Event
    November 30, 2001
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RETURNED FOR INAPPROPRIATE SENSOR RESPONSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 5024M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD