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 or any combination of those symptoms. Dual-Chamber Pacing (Models PM2134 and PM2136 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 PM2134 and PM2136 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 the programmer’s on-screen help.
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. AF Suppression (Models PM2134 and PM2136 only) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing (Models PM2134 and PM2136 only) though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation or silent atria, may provide no benefit beyond that of singlechamber 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, see the programmer’s on-screen help.
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.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.