Study: NCT02817776

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 348 at risk

Adverse event: Cerebrovascular Accident (CVA) / Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Diaphragmatic paralysis
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly device related and possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pulmonary Edema (Respiratory Insufficiency)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 348 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 348 at risk

Adverse event: Major Vascular Access Complication / Bleeding
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 348 at risk

Adverse event: Atrial Fribrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Not Device Related and Not Procedure Related
Frequency: 11 affected / 348 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly device related
Frequency: 1 affected / 348 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Definitely device related
Frequency: 1 affected / 348 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Definitely procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 4 affected / 348 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 4 affected / 348 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 6 affected / 348 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 5 affected / 348 at risk

Adverse event: Complication associated with urinary catheter
Serious: yes
Organ System: General disorders
Notes: Possibly procedure related, not device related
Frequency: 1 affected / 348 at risk

Adverse event: Complication associated with urinary catheter
Serious: yes
Organ System: General disorders
Notes: Definitely procedure related, not device related
Frequency: 2 affected / 348 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Definitely procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Not device related
Frequency: 3 affected / 348 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Definitely procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Not procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 11 affected / 348 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 10 affected / 348 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 6 affected / 348 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 5 affected / 348 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly device related
Frequency: 1 affected / 348 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Definitely procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: possibly procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Back disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Back disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 4 affected / 348 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 3 affected / 348 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Not procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: Not procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Intra-abdominal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Intra-abdominal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 4 affected / 348 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not procedure related
Frequency: 4 affected / 348 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not device related
Frequency: 3 affected / 348 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not procedure related
Frequency: 3 affected / 348 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 2 affected / 348 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Squamous cell cercinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Squamous cell cercinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Not device related
Frequency: 1 affected / 348 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not procedure related
Frequency: 1 affected / 348 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not device related
Frequency: 2 affected / 348 at risk

Adverse event: Cerebrovascular accident (CVA) / Stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Not procedure or device related
Frequency: 1 affected / 348 at risk