BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AROX 60 BP

    MDR report key: 933587 · Received October 25, 2007

    Report

    Report Number
    1028232-2007-00431
    Event Type
    Injury
    Date Received
    October 25, 2007
    Date of Event
    September 24, 2007
    Report Date
    October 2, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K021217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS SYSTEM WAS REMOVED DUE TO EROSION AND PHYSICIAN CHOSE TO UPGRADE TO A CYLOS DR AT THAT TIME. ALSO REMOVED WAS: PHILOS II DR, MDR 1028232-2007-00430, ST JUDE TENDRIL SDX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization