BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS SR

    MDR report key: 567879 · Received January 12, 2005

    Report

    Report Number
    1028232-2004-00157
    Event Type
    Other
    Date Received
    January 12, 2005
    Report Date
    January 3, 2005
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE RETURNED FROM MEDTRONIC WITH NO OOS OR CLINICAL DATA. EXPLANT DATE NOT AVAILABLE.

    Description of Event or Problem · 1

    DEVICE RETURNED FROM MEDTRONIC WITH NO OOS OR CLINICAL DATA. EXPLANT DATE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS SR PACEMAKER DXY BIOTRONIK, INC. 331 446 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization