BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOS DR/CLS

    MDR report key: 777057 · Received November 3, 2006

    Report

    Report Number
    1028232-2006-00230
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 26, 2006
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. OTHER DEVICES RELATED TO THIS SYSTEM: SELOX ST 53, MDR 1028232-06-0233 AND SELOX SR 45, MDR 1028232-06-0231. DEVICES NOT RETURNED TO BIOTRONIK.

    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 65 YR Hospitalization