BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AROX 60 BP

    MDR report key: 1012597 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00220
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 12, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K021217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS NOT RETURNED, HOWEVER MEDTRONIC, INC SENT A REMOVED PRODUCT REPORT BACK WITH THE PACEMAKER OF THIS SYSTEM. PER THE MEDTRONIC REMOVED PRODUCT INFO REPORT, THIS SYSTEM WAS REMOVED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A MEDTRONIC SYSTEM. THERE ARE NO ADVERSE EVENTS REPORTED FOR THE PT. ALSO REMOVED: PHILOS DR-T, 1028232-08-0219; AROX 45 JBP, 1028232-2008-00221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AROX 60 BP PACER LEAD DTB BIOTRONIK GMBH AND CO. 338021

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization