Assurity MRI™ Single-Chamber Pacemaker
CARDIOVASCULAR
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Assurity MRI™

Single-Chamber Pacemaker

PRODUCT HIGHLIGHTS

  • Allows patients to undergo 1.5 T or 3 T MRI scans when used with an MRI Ready lead from Abbott*
  • An optional, easy-to-use hand-held device (SJM MRI Activator™ device) can be used to program the device to pre-approved MRI settings pre- and post- MRI scan, decreasing the number of workflow steps and increasing clinic efficiency
  • Physician preferred size and physiologic shape minimize pocket size
  • InvisiLink™ wireless telemetry, in conjunction with the Merlin@home™ transmitter and Merlin.net™ Patient Care Network (PCN), allows for daily remote monitoring and follow-up Ordering Information Contents: MRI Ready Pacing System
  • CorVue™ congestion monitoring offers greater insight into pulmonary edema status by monitoring transthoracic impedance, and it provides the option for physician alerts
  • A suite of state-of-the-art features — such as automaticity, and Ventricular AutoCapture™ pacing system for ventricular implants, ACap™ Confirm, AF Suppression™ algorithm and AT/AF diagnostics for atrial implants, and SenseAbility™ technology — are designed to deliver optimal therapy for patients at implant and throughout their lives
  • Outstanding longevity provides 13,9 years of service life,1 which is supported by a 10-year warranty2
  • 6-month ERI-EOL interval

ORDERING INFORMATION

Contents: MRI Ready Pacing System


Reorder Number Description Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1272 Assurity MRI Pacemaker 47 x 50 x 6 20 10.4 (± 0.5) IS-1
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*See MRI Ready Systems Manual for MRI scan parameters

1. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON.
2. Terms and conditions apply; refer to the warranty for details.


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: Implantation is indicated in one or more of the following permanent conditions: 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: Single-chamber pulse generators 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. 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 the programmer’s on-screen help.

Potential Adverse Events: The following are potential complications associated with the use of any pacing system: 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 device because of programmer malfunction, infection, interruption of desired device 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 device function due to battery failure or component malfunction, device 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.

26017-EM-ASY-1016-0013(2)

Last Updated: January 02, 2019

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Reorder Number Description Insulation Fixation Minimum Introducer (F) Connector Length (cm)