BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 1081830 · Received July 23, 2008

    Report

    Report Number
    1028232-2008-00766
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P07008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD DISLODGED AFTER IMPLANT AND COULD NOT BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 85-BP LV LEAD LWS BIOTRONIK GMBH AND CO. 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization