BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1851622 · Received September 28, 2010

    Report

    Report Number
    1028232-2010-02012
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    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 CRM RECEIVED INFO THAT LOSS OF CAPTURE (LOC) WAS OBSERVED AND THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED, A LEAD REVISION WAS PERFORMED. DURING THE LEAD REVISION PROCEDURE, THIS LEAD WAS UNABLE TO BE REPOSITIONED DUE TO TISSUE BEING STUCK TO THE HELIX. A NEW LEAD WAS THEN ATTEMPTED HOWEVER, THE PT'S HEART WALL WAS PERFORATED. THE PT REQUIRED PERICARDIOCENTESIS AND INTUBATION. SEVERAL LEADS WERE ATTEMPTED AND REMOVED TO TRY AND MAINTAIN PACING TO STABILIZED THE PT. A LEAD WAS SUCCESSFULLY IMPLANTED CLOSE TO THE RV OUTFLOW TRACT AND PACING WAS STABILIZED. ONCE STABILIZED, A PERICARDIOCENTESIS WAS PERFORMED AND THE FLUID DRAINED FROM THE PERICARDIUM. THE LEAD PLACED NEAR THE RV OUTFLOW TRACT WAS REMOVED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED IN THE RV APEX. TO DATE, NO FURTHER ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization