BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOS DR/CLS

    MDR report key: 1031222 · Received April 14, 2008

    Report

    Report Number
    1028232-2008-00363
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION. PER THE FOLLOWING PHYSICIAN'S OFFICE, THIS DEVICE WAS REMOVED DUE TO POCKET EROSION. THIS DEVICE WAS REPLACED WITH A MEDTRONIC DEVICE. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS DR/CLS PACEMAKER DXY BIOTRONIK GMBH AND CO 122300

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization