BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1941840 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02806
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 15, 2010
    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 DURING THE IMPLANT PROCEDURE AND AFTER THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED, THE PT'S BLOOD PRESSURE DROPPED, LOSS OF VENTRICULAR CAPTURE AND GREATLY VARYING SENSING MEASUREMENTS FOR THE RV LEAD WERE OBSERVED. THIS ACTIVE FIX RV LEAD WAS EXPLANTED AND REPLACED WITH A PASSIVE FIX LEAD. AN ECHOCARDIOGRAM CONFIRMED THAT THE ORIGINAL RV LEAD HAD PERFORATED THE VENTRICLE, AND THERE WAS FLUID IN THE PERICARDIUM; A PERICARDIAL CENTESIS WAS PERFORMED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization