Brief Summary: 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. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.
Indications and Usage: Implantation of Sustain pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia 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.
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: Implanted Cardioverter-Defibrillator (ICD). Because Sustain pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing, Sustain 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.
Potential Adverse Events: Arrhythmia, heart block, thrombosis, threshold elevation, valve damage, pneumothorax, myopotential sensing, vessel damage, 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 rate-modulated 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.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.