BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLS II

    MDR report key: 1071467 · Received June 19, 2008

    Report

    Report Number
    1721279-2008-00014
    Event Type
    Death
    Date Received
    June 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    June 10, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: FEMALE WITH EJECTION FRACTION OF 30-35% WITH A LEFT BUNDLE BRANCH BLOCK. LEFT SIDED ABANDONED DUAL CHAMBER PACEMAKER LEADS IMPLANTED IN 1992. RIGHT SIDED FUNCTIONAL DUAL CHAMBER PACEMAKER SYSTEM IMPLANTED IN 1998. INDICATIONS FOR LEAD REMOVAL: OCCLUSION OF ALL USABLE VEINS WITH THE NEED TO IMPLANT A NEW TRANSVENOUS BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROCEDURE: THE MD SUCCESSFULLY COMPLETED THE REMOVAL OF THE LEADS IMPLANTED ON THE LEFT SIDE AS WELL AS THE REMOVAL OF THE FUNCTIONING DUAL CHAMBER PACING SYSTEM IMPLANTED ON THE RIGHT SIDE. THE MD BEGAN IMPLANTING THE NEW HIGH VOLTAGE RV LEAD AND REALIZED THAT THE PT WENT INTO ASYSTOLE. HE CALLED FOR EXTERNAL PACING AND BEGIN TRYING TO GET A LONG 9F OR 11FR SAFE SHEATH OVER THE WIRE TO GET THE LEAD INTO THE RIGHT VENTRICLE TO PACE THE PT INTERNALLY. THE BP HAD FALLEN SIGNIFICANTLY AND A CODE WAS CALLED. THE CV SURGEON CAME INTO THE ROOM AMD THE PRESSURE REBOUNDED SLIGHTLY AND NO PERICARDIAL EFFUSION WAS NOTED ON ECHO. THE PATIENT'S CONDITION BEGAN TO DETERIORATE SO DYE WAS INJECTED INTO THE SUBCLAVIAN VEIN WHICH REVEALED A SVC LEAK. PATIENT WAS TRANSPORTED TO SURGERY AND EXPIRED DURING THE OPEN HEART PROCEDURE. THE MD BELIEVES THE PROBLEM MAY HAVE OCCURRED WITH THE PLACEMENT OF THE NEW RV LEAD AND IS NOT SPNC DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLS II SPECTRANETICS LASER SHEATH MFA SPECTRANETICS CORP. 500-013

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death SPECTRANETICS CVX-300 LASER