Sustain™ XL SC Single-Chamber Pacemaker
CARDIOVASCULAR
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SustainXL SC

Single-Chamber Pacemaker

Sustain<sup>™</sup> XL SC

PRODUCT HIGHLIGHTS

  • Device features small, physiologic shape and offers superior longevity (12,8 years1) without compromising size.
  • Instant follow-up with automatic P- or R-wave, lead impedance measurements and ventricular threshold tests.
  • 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.

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1134 42 x 52 x 6 23 10.4 IS-1 compatible
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1 V = 2,5 V/0,4 ms, V = 500 ohms, 100% VVI pacing @ 60 bpm; represents shipped nominal SEGM settings (SEGMs "ON," Sampling Option "Freeze," maximum number of stored EGMs "4"). Programming the stored EGM to "Continuous" further reduces the stated longevity. Data on file.

Note: Accepts all IS-1, VS•1 and 3,2 mm leads.


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. Symptomatic bilateral bundle branch block when tachy-arrhythmia 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.

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.

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.

Item GMCRM877EN

Last Updated: January 02, 2019

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