BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS DR

    MDR report key: 647293 · Received November 17, 2005

    Report

    Report Number
    1028232-2005-00157
    Event Type
    Other
    Date Received
    November 17, 2005
    Report Date
    November 15, 2005
    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

    DEVICE RECEIVED FROM MEDICAL CENTER WITH NO OOS OR DOCUMENTATION.

    Description of Event or Problem · 1

    DEVICE RECEIVED 10/24/2005 FROM MUNROE REGIONAL MEDICAL CENTER WITH NO OOS OR DOCUMENTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO., 331443 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other