Pacemakers | Abbott
Reading: Pacemakers | Abbott
* Limited data is available for Aveir LP. The Aveir LP ’ mho predicate device has chronic retrieval achiever rate > 80 % with helix obsession through 7 years careless of plant duration ** ISO standard settings : VVIR, 60bpm, 2.5V @ 0.4 mississippi, 600 Ω, 100 % pace ***Among pacemakers < 15cc in total volume ; as of February 1, 2017 .
Indications, Safety & Warnings
Aveir Leadless Pacemaker System
Rx Only
Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with meaning bradycardia and normal sinus rhythm with rare episodes of A-V block or fistula apprehension, chronic atrial fibrillation and austere physical disability. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increase stimulation rates concurrent with physical action .
Contraindications: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases :
Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-octane shocks could damage the pacemaker and the pacer could reduce electric shock potency .
Single-chamber ventricular requirement pace is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a sink in arterial rake blackmail with the onset of ventricular tempo .
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates .
Use is contraindicated in patients with an implant vein cava filter or mechanical tricuspid valve because of interference between these devices and the delivery organization during implantation .
Persons with know history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials ( listed in Product Materials section in IFU ) contained in the device and a exhaustive history of allergies must be discussed.
Adverse Events: Potential complications associated with the function of the Aveir™ Leadless Pacemaker arrangement are the lapp as with the habit of single chamber pacemakers with active obsession pacing leads including, but not limited to : cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac cardiac arrhythmia, Diaphragmatic/phrenic nerve foreplay / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, medications, or direct toxic consequence of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or dispatch loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP ( non-battery related ), Loss of capture or sensing due to embolization or fibrotic tissue reply at the electrode, Increased capture doorway, Inappropriate detector reaction, Interruption of craved LP function due to electric hindrance, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications ( Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion ), Death .
As with any transdermal catheterization operation, electric potential complications include, but are not limited to : vascular access complications ( such as perforation, dissection, puncture, groin trouble ), Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage, General surgery risks and complications from comorbidities ( such as hypotension, dyspnea, respiratory failure, faint, pneumonia, high blood pressure, cardiac failure, reaction to sedation, nephritic failure, anemia, and death )
consult to the User ’ s Manual for detail indications, contraindications, warnings, precautions and potential adverse events .
Assurity MRI
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Indications: Implantation is indicated in one or more of the follow 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 action. Dual-Chamber Pacing is indicated for those patients exhibiting : disgusted fistula syndrome, chronic, diagnostic second- and third-degree AV stop, perennial Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with venous sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with meaning bradycardia and normal sinus rhythm with alone rare episodes of A-V blockage or sinus apprehension, chronic atrial fibrillation, dangerous physical disability. AF Suppression algorithm is indicated for suppression of paroxysmal or dogged atrial fibrillation episodes in patients with one or more of the above pacing indications .
Contraindications: Dual-chamber pulse generators are contraindicated in patients with an plant 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 appraisal of the highest stimulation rate tolerated by the patient. AF Suppression™ stimulation is not recommended in patients who can not tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial waver, chronic atrial fibrillation, or dumb atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacesetter syndrome, have retrograde VA conduction, or suffer a spend in arterial blood press with the attack of ventricular pace. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction .
Potential Adverse Events: The postdate are electric potential complications associated with the manipulation of any pacing system : cardiac arrhythmia, heart block, thrombosis, brink acme, valve damage, pneumothorax, myopotential sense, vessel damage, air travel embolism, body rejection phenomenon, 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 craved device function due to electric intervention, loss of desire pacing and/or sensing due to lead displacement, torso chemical 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 muscleman foreplay, phrenic steel 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 early than patient activeness, loss of activity-response due to sensor failure, palpitations with high-rate tempo .
consult to the User ’ s Manual for detail indications, contraindications, warnings, precautions and potential adverse events .
Endurity Pacemaker
Rx Only
Indications: Implantation is indicated in one or more of the follow permanent wave conditions : syncope, presyncope, tire, 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 increase foreplay rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting : pale venous sinus syndrome, chronic, diagnostic second- and third-degree AV parry, perennial Adams-Stokes syndrome, diagnostic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. atrial Pacing is indicated for patients with sinus lymph node dysfunction and normal AV and intraventricular conduction systems. ventricular Pacing is indicated for patients with significant bradycardia and convention sinus rhythm with entirely rare episodes of A-V block or fistula collar, chronic atrial fibrillation, severe physical disability. AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pace indications.
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Contraindications: Dual-chamber pulse generators are contraindicated in patients with an implant cardioverter-defibrillator. Rate-Adaptive pace 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 stimulation is not recommended in patients who can not tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial waver, chronic atrial fibrillation or mum atria, may provide no profit beyond that of single-chamber 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 sink in arterial blood blackmail with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction .
Potential Adverse Events: The postdate are electric potential complications associated with the use of any pacing system : cardiac arrhythmia, kernel parry, thrombosis, brink elevation, valve damage, pneumothorax, myopotential sense, vessel damage, air travel embolism, torso rejection phenomenon, cardiac tamponade or perforation, formation of fibrotic tissue/local tissue reaction, inability to interrogate or plan a device because of programmer malfunction, infection, break of desire device serve due to electrical interference, loss of coveted pacing and/or sensing due to lead shift, body reaction at electrode interface or lead malfunction ( fracture or price to insulation ), loss of normal device function due to battery failure or part malfunction, device migration, pocket erosion or hematoma, pectoral muscle stimulation, phrenic heart 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, personnel casualty of activity-response ascribable to sensor failure, palpitations with high-rate pacing .
refer to the User ’ s Manual for detail indications, contraindications, warnings, precautions and potential adverse events .