BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTOS DR

    MDR report key: 660788 · Received January 6, 2006

    Report

    Report Number
    1028232-2005-00221
    Event Type
    Other
    Date Received
    January 6, 2006
    Report Date
    January 3, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PRODUCT RETURNED BY GUIDANT CORPORATION WITH NO OOS REPORT.

    Description of Event or Problem · 1

    PRODUCT RETURNED BY GUIDANT CORP WITH NO OOS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO 122300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other