BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II SR

    MDR report key: 823426 · Received February 2, 2007

    Report

    Report Number
    1028232-2007-00012
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    December 1, 2006
    Report Date
    January 30, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION. THE DATE OF EXPLANT IS UNK, THEREFORE, THE EVENT DATE IS APPROX. ALSO INCLUDED WITH THIS IS A SELOX ST 60, MDR 1028232-07-0015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II SR PACER DTB BIOTRONIK GMBH AND CO. 341824 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization