BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROX 45 JBP

    MDR report key: 823463 · Received February 2, 2007

    Report

    Report Number
    1028232-2007-00017
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    August 14, 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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION. ALSO PART IF THIS SYSTEM ARE CYLOS DR, MDR: 1028232-07-0015 AND SYNOX 53/15 BP, MDR: 1028232-07-0018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROX 45 JBP PACING LEAD DTB BIOTRONIK GMBH AND CO. 124774 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization