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Indications, Safety & Warnings

Abbott ICM (Jot Dx™ ICM and Confirm Rx™ ICM)

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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.

Indications: Abbott Insertable Cardiac Monitors (ICMs) are indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. Abbott ICMs are also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. Abbott ICMs have not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of Abbott ICMs. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with these devices, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

Agilis HisPro Steerable Catheter

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Indication: The Agilis HisPro™ is indicated to provide a pathway for delivery and support of transvenous devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.

Contraindications: Crossing a mechanical tricuspid valve with this device is contraindicated.

Complications: As with any catheterization procedure, potential complications include thromboembolism, local and systemic infection, bleeding or hematoma at the puncture site, vascular dissection or perforation, cardiac perforation, and cardiac tamponade.

Assurity MRI™ pacemaker

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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. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia 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. AF Suppression algorithm is indicated for suppression of paroxysmal or persistent 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 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. AF Suppression™ stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent 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 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.

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.

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

Aveir™ Leadless Pacemaker System

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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

Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:

▪ Normal sinus rhythm with rare episodes of A-V block or sinus arrest

▪ Chronic atrial fibrillation

▪ Severe physical disability

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Intended Use: The Aveir™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.

The Aveir™ Delivery Catheter system is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.

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-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.

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.

Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.

Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.

Persons with known 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 thorough history of allergies must be discussed.

Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete 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 response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, 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 percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications (such as perforation, dissection, puncture, groin pain), 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, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death).

Durata™ Family of Defibrillation Leads

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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 and Usage: The Durata lead is intended for permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy when used with a compatible Abbott pulse generator.

Contraindications: Durata leads are contraindicated in the following:

  • Patients with tricuspid valvular disease or a mechanical tricuspid valve.
  • Patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
  • Patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated.
  • For use with extra firm (red color knob) stylets.

Adverse Events: Potential adverse events include: cardiac tamponade, hemorrhage, pneumothorax, air embolism, venous thrombosis and/or obstruction, tissue necrosis, tricuspid valve dysfunction, infection.

Ellipse™ ICD
Dual-Chamber

CD2411-36Q

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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: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following:

  • Acceleration of arrhythmias (caused by device)
  • Air embolism
  • Allergic reaction
  • Bleeding
  • Cardiac tamponade
  • Chronic nerve damage
  • Death
  • Erosion
  • Exacerbation of heart failure
  • Excessive fibrotic tissue growth
  • Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
  • Extrusion
  • Fluid accumulation
  • Formation of hematomas or cysts
  • Inappropriate shocks
  • Infection
  • Keloid formation
  • Lead abrasion and discontinuity
  • Lead migration/dislodgment
  • Myocardial damage
  • Pneumothorax
  • Shunting current or insulating myocardium during defibrillation with internal or external paddles
  • Potential mortality due to inability to defibrillate or pace
  • Thromboemboli
  • Venous occlusion
  • Venous or cardiac perforation.

Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following:

  • Dependency
  • Depression
  • Fear of premature battery depletion
  • Fear of shocking while conscious
  • Fear of losing shock capability
  • Imagined shocking (phantom shock)

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

Ellipse™ ICD
Single-Chamber

CD1411-36Q

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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: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following:

  • Acceleration of arrhythmias (caused by device)
  • Air embolism
  • Allergic reaction
  • Bleeding
  • Cardiac tamponade
  • Chronic nerve damage
  • Death
  • Erosion
  • Exacerbation of heart failure
  • Excessive fibrotic tissue growth
  • Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
  • Extrusion
  • Fluid accumulation
  • Formation of hematomas or cysts
  • Inappropriate shocks
  • Infection
  • Keloid formation
  • Lead abrasion and discontinuity
  • Lead migration/dislodgment
  • Myocardial damage
  • Pneumothorax
  • Shunting current or insulating myocardium during defibrillation with internal or external paddles
  • Potential mortality due to inability to defibrillate or pace
  • Thromboemboli
  • Venous occlusion
  • Venous or cardiac perforation.

Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following:

  • Dependency
  • Depression
  • Fear of premature battery depletion
  • Fear of shocking while conscious
  • Fear of losing shock capability
  • Imagined shocking (phantom shock)

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

Endurity™ Dual- and Single-Chamber
Pacemaker System

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Indications

Implantation is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, fatigue, disorientation. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; symptomatic bilateral bundle branch block when tachyarrhythmia 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. AF Suppression algorithm stimulation is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Contraindications

Single-chamber and dual-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. AF Suppression algorithm stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation or silent 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 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. add statement: 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; death.

Entrant™ and Gallant™ HF CRT-D

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Intended Use: The Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles.

The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

 

Indications: The CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.

In addition, CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.

MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.

The myMerlinPulse mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

 

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

The myMerlinPulse mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.

 

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious or losing pulse capability. Possible adverse device effects include complications due to the following: Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.

No potential adverse events have been identified with use of the myMerlinPulse mobile application.

Entrant™ and Gallant™ ICD

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Intended Use: The Implantable Cardioverter Defibrillator (ICD) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation.

The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

 

Indications: The ICD devices are indicated for automated treatment of life-threatening ventricular arrhythmias.

In addition, dual chamber ICD devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.

MR Conditional ICDs are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.

The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

 

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.

 

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.

No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.

 

Fortify Assura DR ICD

Rx Only

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 us.

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

Contraindications: Contraindications for pulse generator system use include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRTD system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).

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

Fortify Assura VR ICD

Rx Only

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: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

Possible Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).

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

Quadra Allure MP™
Cardiac Resynchronization Therapy Pacemaker

Rx Only

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 Abbott representative for product availability in your country.
 

Indications

Implantation of Quadra Allure MP device is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure; the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration. Implantation of a single chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, fatigue, disorientation.

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome,;symptomatic bilateral bundle branch block when tachyarrhythmia 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 AV block or sinus arrest; chronic atrial fibrillation; severe physical disability. AF Suppression™ algorithm stimulation is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

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. AF Suppression algorithm stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent 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 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; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; cardiac/coronary sinus dissection; cardiac/coronary sinus perforation; coronary sinus or cardiac vein thrombosis.

Quadra Assura MP™
Cardiac Resynchronization Therapy Defibrillator

RX Only

Brief Summary

Prior to using these devices, please review the Instructions for Use for a complete listing indications, contraindications, warnings, precautions, potential adverse events and directions for use.
 

Indications


The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. Cardiac Resynchronization Therapy Defibrillators (CRT‑Ds) are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

Contraindications

Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

Adverse Events

Possible adverse events (in alphabetical order) associated with the system include, but are not limited to, the following: Acceleration of arrhythmias (caused by device), Air embolism, Allergic reaction, Bleeding, Cardiac tamponade, Chronic nerve damage, Death, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, chest wall), Extrusion, Fluid accumulation, Formation of hematomas or cysts, Inappropriate shocks, Infection, Keloid formation, Lead abrasion and discontinuity, Lead migration/dislodgment, Myocardial damage, Pneumothorax, Shunting current or insulating myocardium during defibrillation with internal or external paddles, Potential mortality due to inability to defibrillate or pace, Thromboemboli, Venous occlusion, Venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: Dependency, Depression, Fear of premature battery depletion, Fear of shocking while conscious, Fear of losing shock capability, Imagined shocking (phantom shock).

Quartet LV Lead

Rx Only

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 and Usage: The Quartet LV lead is intended for permanent sensing and pacing of the left ventricle when used with a compatible Abbott biventricular system.

Contraindications: The use of the Quartet LV lead is contraindicated in patients who:

  • Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate.
  • Are unable to undergo an emergency thoracotomy procedure.
  • Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Adverse Events: Potential adverse events associated with the use of left ventricular leads include: cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, cardiac tamponade, coronary sinus or cardiac vein thrombosis, death, endocarditis, excessive bleeding, hematoma/seroma, induced atrial or ventricular arrhythmias, infection, lead dislodgment, local tissue reaction, formation of fibrotic tissue, myocardial irritability, myopotential sensing, pectoral/diaphragmatic/phreni c nerve stimulation, pericardial effusion, pericardial rub, pneumothorax/hemothorax, pulmonary edema, thrombolytic or air embolism, valve damage.

Tendril Family of Pacing Leads

Rx Only

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.

Indications: The Tendril STS™ Model 2088TC and Tendril MRI™ Model LPA1200M leads are designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active leads such as the Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of the screw-in leads such as Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications: The Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads are contraindicated: in the presence of tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Events: Potential complications associated with the use of Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads are the same as with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation, embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.

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

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.