BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2187966 · Received August 2, 2011

    Report

    Report Number
    2124215-2011-13217
    Event Type
    Death
    Date Received
    August 2, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE CLEAR MEDICAL ADHESIVE WAS SEPARATED FROM THE GORE, AT THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE. THE SEPARATION WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. ALTHOUGH UNDER NORMAL CIRCUMSTANCES SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE RELIABILITY OF THE LEAD, TO REDUCE THE OCCURRENCE OF SUCH DAMAGE USE OF A TRANS-VALVULAR INSERTION (TVI) TOOL IS RECOMMENDED WHEN USING A HEMOSTATIC TEAR-AWAY INTRODUCER. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DIED DURING THE IMPLANT PROCEDURE. THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 220/180 AND WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS BEING POSITIONED, IT WENT INTO THE CORONARY SINUS (CS), IT EVENTUALLY WAS ABLE TO BE REPOSITIONED. NEXT ATTEMPTS WERE MADE TO CANNULATE THE CS. A WIRE WAS PLACED IN THE CS THEN CARDIAC STANDSTILL WAS OBSERVED. THE PATIENT DEVELOPED CARDIAC TAMPONADE WITH ELECTROMECHANICAL DISSOCIATION. IT WAS SUSPECTED THAT THE RV LEAD MAY HAVE CAUSED THE PERFORATION WHEN IT ENTERED THE CORONARY SINUS. PERICARDIOCENTESIS WAS PERFORMED AND GREATER THAN TWO LITERS OF BLOOD WAS REMOVED. HOWEVER, THE PATIENT WAS NOT ABLE TO BE REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Death