BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 75-UP STEROID

    MDR report key: 2872594 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03149
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 26, 2012
    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 LEAD WAS CAPPED AND REPLACED DUE TO DIAPHRAGMATIC STIMULATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 75-UP STEROID LV LEAD NKE BIOTRONIK SE & CO. KG 346542

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization