BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2140754 · Received June 15, 2011

    Report

    Report Number
    1028232-2011-01299
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    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 VENTRICULAR LEAD WAS NOT CAPTURING IN BIPOLAR CONFIGURATION. INTERMITTENT CAPTURE WAS NOTED IN UNIPOLAR CONFIGURATION. AS A RESULT, THIS LEAD WAS EXPLANTED. NO 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