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 Zephyr® 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 is indicated for patients with chronotropic incompetence,* and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Models 5826, 5820 only) is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. 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. AF Suppression (Models 5826, 5820 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
For specific indications associated with individual modes, refer to Operating Modes.
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Because Zephyr® pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing, Zephyr devices are contraindicated in patients with an implanted cardioverter- defibrillator. Rate-Adaptive Pacing 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. AF Suppression (Models 5826, 5820 only) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing (Models 5826, 5820 only) though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. 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.
For specific contraindications associated with individual modes, refer to Operating Modes.
Potential Adverse Events: Adverse events associated with the use of any pacing system include: Air embolism, bleeding hematoma, body rejection phenomena, cardiac tamponade or perforation, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface, 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 device function due to battery failure or component malfunction, pacemaker migration, pocket erosion, or hematoma, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
*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.