Study: NCT02879448

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 934 at risk

Adverse event: Aplastic Anemia/Hypoplastic Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Aortic Valve Insufficiency/Aortic Valve Regurgitation/Valvular Regurgitation Aortic Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: High Grade Block/Advanced AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 934 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 934 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 934 at risk

Adverse event: Aortic Aneurysms
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 934 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 934 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 934 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Cardiac Thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 934 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 113 affected / 934 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 934 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 934 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 934 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 934 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 934 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 934 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 934 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 934 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Supravalvular aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 934 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 934 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 934 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 934 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 934 at risk

Adverse event: Hemorrhoids/Piles
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hemiparesis/Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 934 at risk

Adverse event: Damage or Movement of ICD Leads Requiring Revisions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 934 at risk

Adverse event: Fatigue/Generalized Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 934 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 934 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 934 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 934 at risk

Adverse event: Choledocholithiaisis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 934 at risk

Adverse event: Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Subacute Bacterial Endocarditis (SBE)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Acute Bacterial Endocarditis (ABE)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 934 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 934 at risk

Adverse event: Pneumonia chlamydial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 934 at risk

Adverse event: Respiratory Syncytial Virus Infection (RSV)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 934 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 934 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Air Embolus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 934 at risk

Adverse event: Epidural Hematomas
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Esophageal Laceration and Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 934 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 934 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 934 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 934 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: VASC Vessel Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 934 at risk

Adverse event: EKG Abnormalities
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 934 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 934 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 934 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 934 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 934 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 934 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 934 at risk

Adverse event: Leukemias
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 934 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 934 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 934 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 934 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 934 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 57 affected / 934 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Unmasking Old Stroke Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 934 at risk

Adverse event: Cerebral Aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 934 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 934 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 934 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Neuralgic Facial Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: New and Different Onset of Migraine Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 934 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Seizure Disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 934 at risk

Adverse event: Spells
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 934 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 934 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 934 at risk

Adverse event: Device Malposition or Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 934 at risk

Adverse event: Thrombus on Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 934 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 934 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 934 at risk

Adverse event: Kidney Cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 934 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 934 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 934 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 934 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Urinary Calculi
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 934 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 934 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 934 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 934 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 934 at risk

Adverse event: Residual Shunt Requiring Closure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 934 at risk

Adverse event: Surgical Closure of ASD
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 934 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Seroma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Vascular Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 934 at risk

Adverse event: Abdominal Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 934 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 934 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 934 at risk

Adverse event: Carotid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 934 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 934 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 934 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 934 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 934 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 934 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Peripheral Arterial Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 934 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 934 at risk

Adverse event: Peripheral Venous Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 934 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 934 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: Investigations
Frequency: 2 affected / 934 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 934 at risk

Adverse event: Air Embolus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Allergic Dye Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 934 at risk

Adverse event: Aortic valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 934 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Arteriovenous malformation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 934 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 934 at risk

Adverse event: Blood Loss
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Borderline Prolongation of QT Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 934 at risk

Adverse event: Cardiac Thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 934 at risk

Adverse event: Carotid Stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 934 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 934 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 934 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 934 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 934 at risk

Adverse event: Device Malposition or Malfunction
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 934 at risk

Adverse event: Diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Diplopia/Double Vision
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Dysarthria/Slurred Speech
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 934 at risk

Adverse event: Echo Finding
Serious: no
Organ System: Investigations
Frequency: 1 affected / 934 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 934 at risk

Adverse event: Eye Bleed
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 934 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 934 at risk

Adverse event: Fatigue/Generalized Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 934 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 934 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 934 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 934 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 934 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 934 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 934 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Iron-Deficiency Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Lacerations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 934 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 934 at risk

Adverse event: Malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 934 at risk

Adverse event: Memory Difficulty
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 934 at risk

Adverse event: New and Different Onset of Migraine Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 934 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 934 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 934 at risk

Adverse event: Patent Foramen Ovale (PFO)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 934 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 934 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 934 at risk

Adverse event: Peripheral Venous Thrombus
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 934 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 934 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Residual Shunt
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 934 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 934 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Skin Bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 934 at risk

Adverse event: Spells
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 934 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 934 at risk

Adverse event: Transient global amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 934 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 934 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 934 at risk

Adverse event: Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 934 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 934 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 934 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 934 at risk

Adverse event: VASC Bruise
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 934 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 934 at risk

Adverse event: VASC Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 934 at risk

Adverse event: Wenckebach (Mobitz I) Block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 934 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 934 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 944 at risk

Adverse event: Aplastic Anemia/Hypoplastic Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Iron-Deficiency Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 944 at risk

Adverse event: Aortic Valve Insufficiency/Aortic Valve Regurgitation/Valvular Regurgitation Aortic Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: High Grade Block/Advanced AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 944 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 944 at risk

Adverse event: Aortic Aneurysms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 944 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 944 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cardiac Thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 944 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 105 affected / 944 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 944 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 944 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 944 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 944 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 944 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Perivalvular Leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 944 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 944 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 944 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 944 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Eye Bleed
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 944 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Emesis/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 944 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 944 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 944 at risk

Adverse event: Fatigue/Generalized Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 944 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 944 at risk

Adverse event: Neck pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 944 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 944 at risk

Adverse event: Ascites
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 944 at risk

Adverse event: Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Bacterial Infections of the Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Infected cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 944 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 944 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 944 at risk

Adverse event: Air Embolus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 944 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 944 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Esophageal Laceration and Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 944 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 944 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 944 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 944 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 944 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 944 at risk

Adverse event: VASC Vessel Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Abnormal Coagulation Parameter
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 944 at risk

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 944 at risk

Adverse event: Echo Finding
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 944 at risk

Adverse event: Poor Nutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 944 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 944 at risk

Adverse event: Leukemias
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 944 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 944 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 944 at risk

Adverse event: Dysarthria/Slurred Speech
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 944 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 53 affected / 944 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Altered Sensorium
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Bells Palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Cerebral Aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 944 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 944 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 944 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 944 at risk

Adverse event: Spells
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 944 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 944 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 944 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 944 at risk

Adverse event: Device Malposition or Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 944 at risk

Adverse event: Thrombus on Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 944 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 944 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 944 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 944 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 944 at risk

Adverse event: Renal infarct
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 944 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 944 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 944 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 944 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 944 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 944 at risk

Adverse event: Residual Shunt Requiring Closure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 944 at risk

Adverse event: Surgical Closure of ASD
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 944 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 944 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 944 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 944 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 944 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 944 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 944 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 944 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 944 at risk

Adverse event: Peripheral Arterial Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 944 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 944 at risk

Adverse event: Peripheral Venous Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 944 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 944 at risk

Adverse event: Air Embolus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Allergic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 944 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 944 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 944 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 944 at risk

Adverse event: Cardiac Thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 944 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 944 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 944 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Decreased Left Ventricular (LV) Function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 944 at risk

Adverse event: Device Malposition or Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 944 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Dysarthria/Slurred Speech
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Oedema
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 944 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 944 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 944 at risk

Adverse event: Eye Bleed
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 944 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 944 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 944 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 944 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 944 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 944 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: Iron-Deficiency Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Lacerations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 944 at risk

Adverse event: Loss of Speech/Stuttering
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Mononeuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 944 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 944 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 944 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Paresthesia/Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 944 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Patent Foramen Ovale (PFO)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 944 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Peripheral Venous Thrombus
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 944 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 944 at risk

Adverse event: Pruritis/Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 944 at risk

Adverse event: Residual Shunt
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 944 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 944 at risk

Adverse event: ST Segment Changes
Serious: no
Organ System: Investigations
Frequency: 1 affected / 944 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Skin Bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 944 at risk

Adverse event: Skin Lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 944 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 944 at risk

Adverse event: Spells
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 944 at risk

Adverse event: Subdural haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 944 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 944 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 944 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 944 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 944 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 944 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 944 at risk

Adverse event: VASC AV Fistula
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 944 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 944 at risk

Adverse event: VASC Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 944 at risk

Adverse event: VASC Pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 944 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 944 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 944 at risk