CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: Implantation of Identity ADx® pulse generators is indicated in the following permanent conditions, when associated with symptoms, including but not limited to: syncope, presyncope, fatigue, disorientation or any combination of those symptoms. Rate-Modulated Pacing ( Models 5386, 5380, 5180 only) is indicated for patients with chronotropic incompetence,* and for those who would benefit from increased stimulation rates concurrent with physical activity. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability.
Contraindications: Unipolar Pacing and Implanted Cardioverter-Defibrillator (ICD). A unipolar pacing configuration (which is required for the operation of the AutoCapture™ Pacing System) is contraindicated in patients with an ICD. Rate-Adaptive Pacing (Models 5386, 5380, 5180 only) may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.
Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program a pulse generator because of programmer malfunction, infection, interruption of desired pulse generator function due to electrical interference, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal pacemaker function due to battery failure or component malfunction, pacemaker migration, pocket erosion or hematoma, pectoral muscle stimulation, phrenic nerve or diaphragmatic stimulation.
The following, in addition to the above, are potential complications associated with the use of ratemodulated pacing systems: inappropriate, rapid pacing rates due to sensor failure or to the detection of signals other than patient activity, loss of activity-response due to sensor failure, palpitations with high-rate pacing.
* Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 ppm during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197—(0.56 x age). Gwinn N, Leman R, Kratz J, et al. Chronotropic incompetence: A common and progressive finding in pacemaker patients. American Heart Journal 1992; 123:1216-19.