Approved for Use: United States & International. This device is approved for use in the United States and internationally.
Indications & Usage
The Epic® II and Epic® II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR and Epic II+ HF devices, AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, the Epic II HF and Epic II+ HF systems are also intended:
- To provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration.
- To maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.
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.
Warnings & Precautions
Resuscitation availability: Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are readily available.
Lead system: Do not use another manufacturers lead system without demonstrated compatibility as undersensing cardiac activity and failure to deliver necessary therapy may result.
Avoiding shock during handling: Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program the device to Defib Off mode during surgical implant and explant or post-mortem procedures as well as when disconnecting leads as the device can deliver a serious shock if you touch the defibrillation terminals while the device is charged.
Additional pacemaker implant required: The Epic II HF and Epic II+ HF CRT-Ds provide dual-chamber bradycardia pacing with ventricular resynchronization therapy. The Epic II DR and Epic II+ DR ICDs provide dual-chamber bradycardia pacing. The Epic II VR pulse generator provides single-chamber bradycardia pacing. If another pacemaker is used, it should have a bipolar pacing reset mode and be programmed for bipolar pacing to minimize the possibility of the output pulses being detected by the device.
Electromagnetic Interference
Patients should be directed to avoid devices which generate a strong electric or magnetic interference (EMI). EMI could cause device malfunction or damage, resulting in non-detection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation.
Electrosurgical cautery: Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage. If electrocautery is necessary, keep the current path and groundplate as far away from the pulse generator and leads as possible.
External defibrillation: External defibrillation may damage the pulse generator or may result in temporary and/or permanent myocardial damage at the electrode-tissue interface as well as temporarily or permanently elevated pacing capture thresholds. Minimize current flowing through the pulse generator and lead system by following these precautions when using external defibrillation on a patient with a pulse generator:
- Position defibrillation paddles as far from the pulse generator as possible (minimum of 5 inches [13 cm])
- Use the lowest clinically appropriate energy output
- Confirm pulse generator function following any external defibrillation
High radiation sources: Do not direct high radiation sources such as cobalt 60 or gamma radiation at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage and confirm its function after treatment.
Lithotripsy: Lithotripsy may permanently damage the pulse generator. Avoid it unless the therapy site is not near the pulse generator and leads.
Diathermy: Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may permanently damage the pulse generator.
Magnetic resonance imaging (MRI): MRI for patients with implantable pulse generators has been contraindicated by MRI manufacturers. Clinicians should carefully weigh the decision to use MRI with ICD/CRT-D patients. MRI may cause device malfunction or injury to the patient.
Ultrasound therapy: Diagnostic and therapeutic ultrasound treatment is not known to affect the function of the pulse generator.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS may interfere with device function. To reduce interference, place the TENS electrodes close to one another and as far from the device/lead system as possible. Monitor cardiac activity during TENS use.
Radiofrequency ablation: Radiofrequency (RF) ablation in a patient with a pulse generator may cause device malfunction or damage. Minimize RF ablation risks by:
- Programming the device to Defib Off and Pacer Off
- Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator
- Positioning the groundplate so that the current pathway does not pass near the pulse generator system, i.e., place the groundplate under the patients buttocks or legs
- Having external defibrillation equipment available.
Potential Adverse Events
Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during, defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear that shocking capability may be lost, imagined shocking (phantom shock).
Refer to the Users Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
