Study: NCT02091440

Adverse event: Bleeding requiring re-hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 6 at risk

Adverse event: Bleeding requiring re-operation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 6 at risk

Adverse event: Ventricular Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Supraventricular Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Driveline Exit Site Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hemorrhagic Cerebrovascular Accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chronic Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory Dysfunction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Right Heart Failure requiring inotropic therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Bleeding requiring re-hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 6 at risk

Adverse event: Bleeding requiring re-operation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 6 at risk

Adverse event: Ventricular Cardiac Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 6 at risk

Adverse event: Supraventricular Cardiac Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 6 at risk

Adverse event: Device Malfunction/Failure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 6 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Driveline Exit Site Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Hemorrhagic Cerebrovascular Accident
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pericardial Fluid Collection
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Acute Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chronic Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory Dysfunction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Right Heart Failure requiring inotropic therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 6 at risk