BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 1872458 · Received October 8, 2010

    Report

    Report Number
    1028232-2010-02156
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 14, 2010
    Report Date
    September 13, 2010
    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 (CRM) REC'D INFORMATION THAT THIS LEAD WAS EXPLANTED. INSULATION BREAKS OR TEARS WERE OBSERVED IN THE LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    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