BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2800285 · Received October 9, 2012

    Report

    Report Number
    1028232-2012-02531
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISPLAYED A LOSS OF CAPTURE (LOC) AND WAS FOUND TO BE DISLODGED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PT EFFECTS.

    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