BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELOX EX 60-BP

    MDR report key: 1416137 · Received July 14, 2009

    Report

    Report Number
    1028232-2009-00891
    Event Type
    Injury
    Date Received
    July 14, 2009
    Date of Event
    June 8, 2009
    Report Date
    June 16, 2009
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K994240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PACEMAKER, BUT NOT THE LEADS, WERE RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. PER BIOTRONIK PATIENT TRACKING, THIS SYSTEM WAS REMOVED DUE TO INFECTION. THIS SYSTEM HAS NOT BEEN REPLACED. PHILOS DR, MDR 1028232-2009-00890, ELOX EX 45-BP, MDR 1028232-2009-00892.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX EX 60-BP PACER LEAD DTB BIOTRONIK, GMBH AND CO. 330133

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization