BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4137

    MDR report key: 1131804 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00955
    Event Type
    Death
    Date Received
    August 21, 2008
    Date of Event
    April 7, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THAT THIS PATIENT PRESENTED IN THE EMERGENCY ROOM WITH LOSS OF CAPTURE ON THIS RIGHT VENTRICULAR (RV) LEAD 4087. THE SR INCREASED THE DEVICE PACING OUTPUT AND CAPTURE WAS ACHIEVED AT 6.5V AND THE PATIENT WAS REPORTED STABLE. THE PHYSICIAN ELECTED TO SURGICALLY ABANDON RV LEAD 4087 DUE TO THE CHANGE IN THRESHOLD MEASUREMENTS AND NOTED THERE WAS NO INTEGRITY PROBLEM WITH THIS LEAD. THE PATIENT HAD AN UNDERLYING RHYTHM AND COMPLETE HEART BLOCK. THE PHYSICIAN THEN IMPLANTED A NEW RV LEAD 4137. THE PATIENT DEVELOPED TAMPONADE DUE TO THIS NEW LEAD IMPLANT. THE POCKET WAS CLOSED AND CPR ATTEMPTED, HOWEVER PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK, GMBH AND CO. 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death