BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 85-UP STEROID

    MDR report key: 1211776 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01278
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. PER THE OOS, THIS LEAD BECAME DISLODGED, AND PULLED BACK INTO THE SUBCLAVIAN. THIS LEAD WAS REPLACED WITH A COROX OTW 85-BP. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 85-UP STEROID LV LEAD DTB BIOTRONIK GMBH AND CO. 346543

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization