BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1770118 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01532
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    March 27, 2010
    Report Date
    July 2, 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 THIS RIGHT ATRIAL LEAD DISLODGED. DURING THE LEAD REVISION PROCEDURE, THE LEAD WOULD NOT STAY IN PT'S ATRIUM. VISUAL INSPECTION NOTED THE HELIX WAS NOT MOVING AND TISSUE AND BECOME STUCK TO THE HELIX. THE LEAD WAS THEREFORE, SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization