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: Abbott Medical ICDs 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 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.
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: Abbott Medical ICDs 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 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.
MAT-2009641 v2.0
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