BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2232542 · Received August 19, 2011

    Report

    Report Number
    1028232-2011-01866
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 8, 2011
    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 RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. REPOSITIONING WAS ATTEMPTED HOWEVER, WAS UNSUCCESSFUL. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THERE WAS BLOOD AND TISSUE ON THE HELIX AND THE HELIX APPEARED TO WORK FINE.

    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