BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS DR

    MDR report key: 567852 · Received January 12, 2005

    Report

    Report Number
    1028232-2004-00142
    Event Type
    Other
    Date Received
    January 12, 2005
    Report Date
    December 15, 2004
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PRODUCT RETURNED FROM MEDTRONIC WITH NO OOS REPORT AND NO REASON OF EXPLANT. NO EXPLANT DATE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DXY BIOTRONIK, INC. 331 443 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization