BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 85-BP

    MDR report key: 1770161 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01556
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD BECAME DISLODGED AND WHILE IN PLACE THIS LEAD EXHIBITED DIAPHRAGMATIC STIMULATION. THIS LEAD WAS REPLACED WITH A COROX OTW-S 85-BP, (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 354807

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization