BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2833059 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02746
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 25, 2012
    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 INFO THAT THIS LEAD PERFORATED THE PT, SO IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT LEAD. 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