ENSITE X

Indications

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

Warnings

• For patient safety, any connections that directly connect the patient to the EnSite™ X EP System must be routed through the appropriate modules: EnSite™ X EP System SurfaceLink Module, EnSite™ X EP System 20 pin Catheter Input Module, EnSite™ X EP System 80-pin Catheter Input Module and Direct Connect Ports on the EnSite™ X EP System Amplifier.
• When using the EnSite™ X EP System, full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.
• The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.
• Non-SE catheters cannot collect location data and should not be used for navigation in VoXel Mode because they do not have a magnetic sensor. However, they can be visualized and display intracardiac signals.
• Only connect items that have been specified as part of the EnSite X EP System or compatible with the EnSite X EP System to the multiple socket-outlets.
• The EnSite™ X EP System model display should be used in conjunction with conventional EP techniques to confirm catheter location.
• The AutoMark feature does not indicate lesion effectiveness. AutoMarks are placed based on user-defined parameters for catheter stability and RF metrics only.
• Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift.

Precautions

• Ensure that surface electrodes, Patient Reference Sensors, and associated connectors do not contact one another, electrical ground, or metallic objects.
• Ensite™ X EP System components should be connected to power through an isolation transformer or the multiple socket outlet supplied with the system carts. Connecting equipment directly to a wall outlet may result in excessive leakage current.
• Do not operate the EnSite™ X EP System Field Frame within 10 m of another operating Field Frame.
• Do not place the EnSite™ X EP System Field Frame Cable inside the measurement volume or wrap it around the EnSite™ X EP System Field Frame, as it may create a magnetic interference.
• Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may cause metal distortion.
• Do not place tool cables within 30 mm of the EnSite™ X EP System Field Frame Cable. If placed this close-particularly if the cables are parallel to each other the tool cable may become subject to electromagnetic interference.
• Do not use the EnSite™ X EP System in the presence of other magnetic fields.
• Do not drop the EnSite™ X EP System Field Frame or subject it to impact. Physical damage to the EnSite™ X EP System Field Frame may alter the EnSite™ X EP System Field Frame's factory calibration.

Rx Only

Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Intended Use: The Implantable Cardioverter Defibrillator (ICD) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation.

Indications: The ICD devices are indicated for automated treatment of life-threatening ventricular arrhythmias. In addition, dual chamber ICD devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.MR Conditional ICDs are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction. The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices. 

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices. 

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events. No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.