Accent MRI™ SR Single-Chamber Pacemaker with Wireless Telemetry
CARDIOVASCULAR
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Accent MRI™ SR

Single-Chamber Pacemaker with Wireless Telemetry

Accent MRI<sup>TM</sup> SR

PRODUCT HIGHLIGHTS

  • The Accent MRI pacemaker has been designed and tested for safe performance of a full-body MRI scan, without zone restrictions,1 using a 1,5 T (Tesla) field-strength MRI scanner.1 The MRI conditional device:
    – Allows a maximum whole body averaged specific absorption rate (SAR) of 4 watts per kilogram (W/kg) for high image resolution
    – Must be used in conjunction with an MRI lead from St. Jude Medical
  • 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
  • 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
  • State-of-the-art features—such as automaticity, Ventricular AutoCapture™ Pacing System and SenseAbility™technology—are designed to deliver optimal therapy for patients at implant and throughout their lives
  • Industry-leading longevity offers 13,7 years of service life,2 which is supported by a 7-year warranty3

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1224 52 x 53 x 6 24 13.1 (± 0.5) IS-1
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Radiopaque markers

1. The St. Jude Medical™ MRI conditional pacing system can be scanned in patients under the following conditions: horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode; static magnetic field strength of 1,5 Tesla (T) only; maximum gradient slew rate of 200 T/m/s per axis. See manual for additional details before performing an MRI scan.

2. V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacing @ 60 bpm; AutoCapture Pacing System OFF; SEGMs ON

3. 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 of a single-chamber pulse generator 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. MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St. Jude Medical MRI conditional pacing system. 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 (ICD). 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.

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, and 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, and palpitations with high-rate pacing.

Refer to the User’s Manual for more detailed indications, contraindications, warnings, precautions and potential adverse events.

Item GMCRM910EN

Last Updated: December 18, 2018

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