Sustain™ XL DR Dual-Chamber Rate-Responsive Pacemaker
CARDIOVASCULAR
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SustainXL DR

Dual-Chamber Rate-Responsive Pacemaker

PRODUCT HIGHLIGHTS

  • Device features small, physiologic shape and offers superior longevity (9,8 years) without compromising size.1
  • Instant follow-up with automatic P- or R-wave, lead impedance measurements and ventricular threshold tests.
  • Ventricular Intrinsic Preference (VIP) algorithm automatically searches for intrinsic conduction.
  • The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beatcapture confirmation.
  • Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated event markers that precede and follow a specific triggering event.
  • The system also includes the clinically proven Omnisense accelerometer sensor, featuring auto rest rate (based on activity rather than on preset clock settings) and auto rate response.

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM2136 44 x 52 x 6 23.5 11 IS-1

1. A, V = 2,5 V/0,4 ms, A,V = 500 ohms, 100% DDD pacing @ 60 bpm, SEGMs ON; data on file.


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. 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. 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 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. 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.

Item GMCRM910EN

Last Updated: January 02, 2019

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