BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELOX EX 45-BP

    MDR report key: 2070304 · Received April 18, 2011

    Report

    Report Number
    1028232-2011-00840
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 12, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K994240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO ENDOCARDITIS AND WAS REPLACED WITH A COMPETITOR'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX EX 45-BP PACER LEAD DTB BIOTRONIK SE & CO. KG 330132

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization