BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW 85

    MDR report key: 859183 · Received May 31, 2007

    Report

    Report Number
    1028232-2007-00158
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    April 5, 2007
    Report Date
    May 9, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED FROM THE BODY AS THE LEAD BECAME DISLODGED. IT IS NOTED BY L. GOLDSMITH OF BIOTRONIK THAT THE CORONARY SINUS IS A VERY LARGE VESSEL IN THIS PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization