BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1910257 · Received November 22, 2010

    Report

    Report Number
    1028232-2010-02567
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT DURING AN ATTEMPTED LEAD PLACEMENT, THE SUPERIOR VENA CAVA WAS PERFORATED AND CONTRAST WAS INJECTED INTO THE MEDIASTINUM. THE PROCEDURE WAS STOPPED AND THE POCKET CLOSED. AN ECHOCARDIOGRAM WAS PERFORMED, AND A SURGEON AND RADIOLOGIST WERE CONSULTED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization