BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2833060 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02744
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 24, 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 WAS USED IN AN OFF-LABEL MANNER AS THE PHYSICIAN PUT THE LEAD INTO THE RIGHT ATRIAL (RA) PORT WITHIN THE DEVICE, BUT PLACED THE LEAD INTO THE RIGHT VENTRICLE. APPROXIMATELY THREE WEEKS LATER THE LEAD DISLODGED INTO THE RIGHT ATRIUM AND WAS OVERSENSING CREATING INAPPROPRIATE VENTRICULAR TACHYCARDIA (VT) EPISODES. THE 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