Study: NCT02347189

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Device breakage
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Prosthetic valve endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Central Nervous System Disorder*
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 39 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Adverse event
Serious: no
Organ System: General disorders
Frequency: 7 affected / 39 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Upper Repiratory Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 39 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 39 at risk