Ellipse

Implantable Cardioverter Defibrillator

Indications, Safety & Warnings

Ellipse™ ICD
Dual-Chamber

CD2411-36Q

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. 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

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. 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.

MAT-2009641 v1.0