BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 75-UP STEROID

    MDR report key: 1231649 · Received November 14, 2008

    Report

    Report Number
    1028232-2008-01463
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER STUDY ADVERSE EVENT FORM, THIS LEAD HAD PHERNIC NERVE STIMULATION. THE VENTRICULAR OUTPUT WAS RE-PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 75-UP STEROID LV LEAD MRM BIOTRONIK GMBH AND CO 346542

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization