BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIKOS 01

    MDR report key: 660780 · Received January 6, 2006

    Report

    Report Number
    1028232-2005-00211
    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 CORP WITH NO OOS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIKOS 01 PACEMAKER DXY BIOTRONIK GMBH AND CO. 120830 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other