BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 1163055 · Received September 12, 2008

    Report

    Report Number
    1028232-2008-01105
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED. "UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE LEAD IN THE PULMONARY ARTERY." THE PHYSICIAN REPLACED THIS LEAD WITH ANOTHER COROX OTW-S 85-BP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization