BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 2253959 · Received September 14, 2011

    Report

    Report Number
    1028232-2011-02150
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    September 6, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED TO A HIGH LATERAL POSITION AND ALL RECORDS INDICATE IT REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-L 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368345

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization