CARDIOVASCULAR
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Accent® SR

Single-Chamber Pacemaker

Accent® SR

PRODUCT HIGHLIGHTS

  • Inductive remote follow-up utilizing a wand, in conjunction with the Merlin@home® transmitter and Merlin.net® Patient Care Network(PCN), allows patients to download information and provide the clinic with access to device measurements.
  • A two-tone audible alert allows programming to notify the patient of changes in device performance or arrhythmia status, which can provide earlier insight into actionable clinical events.
  • Ventricular AutoCapture Pacing System offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beatcapture confirmation. The Ventricular AutoCapture Pacing System automatically delivers a 5.0 V backup safety pulse when noncapture is detected, and it may be programmed to either a bipolar or unipolar configuration.
  • Exclusive SenseAbility® feature, with Decay Delay and Threshold Start, provides the flexibility to fine-tune sensing to individual patient needs and help eliminate oversensing of T waves, fractionated QRS complexes and other extraneous signals.
  • Real-time electrogram (EGM) waveform, as well as the associated event markers that precede and follow a specific triggering event, can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options.
  • Weekly Lead Impedance Trend displays the current measurement, historical test results, pacing polarity and any polarity switches.

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1110 42 x 52 x 6 18 9.5¹ IS-1
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1 ± 0.5 cc


CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

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: Implanted Cardioverter-Defibrillator (ICD). 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. 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: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma, bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface, 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, pacemaker migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax, device migration and pocket erosion, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage.

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

Rev.6-012511

Last Updated: January 02, 2019

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