BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2192635 · Received August 5, 2011

    Report

    Report Number
    2124215-2011-13389
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPIRED SOON AFTER THE IMPLANT PROCEDURE WAS COMPLETED. THE PATIENT HAD A RE-VASCULARIZATION PROCEDURE PERFORMED TWO DAYS PRIOR TO THIS IMPLANT. THE PATIENT WAS INTUBATED AND HAD THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANTED. TWO DEFIBRILLATION THRESHOLD (DFT) TESTS WERE PERFORMED (21 JOULES NON-CONVERSION; 31 JOULES SUCCESSFUL CONVERSION). POST PROCEDURE THE PATIENT WAS EXTUBATED HOWEVER WAS NOT BREATHING SO THE PATIENT WAS RE-INTUBATED AND CPR STARTED. THE PATIENT HAD CARDIAC ELECTRICAL ACTIVITY OBSERVED BUT NO PULSE. AN ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION SLIGHTLY LARGER THAN WHAT WAS SEEN PRE-OP. THE SURGEON ATTEMPTED TO TAP THE PERICARDIUM BUT FOUND CLOTTED MATERIAL. THE CHEST WAS OPENED AND THE SURGEON FOUND THE RIGHT VENTRICLE WAS HEAVILY SCARRED AND NOT MOVING. MORE BLOOD WAS PULLED OUT OF THE PERICARDIUM. THE PATIENT WAS LATER PRONOUNCED DEAD. IT WAS NOT SPECIFIED IF THE LEADS OR DEVICE WERE EXPLANTED.

    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 56 YR Death E110| 4470| 0185