BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIS SR

    MDR report key: 592933 · Received April 13, 2005

    Report

    Report Number
    1028232-2005-00030
    Event Type
    Other
    Date Received
    April 13, 2005
    Report Date
    April 13, 2005
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE RETURNED WITH INCOMPLETE OOS AND NO CLINICAL DATA. INCOMPLETE OOS INDICATES PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIS SR PACEMAKER DKY BIOTRONIK GMBH & CO. 331 446 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization