Study: NCT01751022

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 499 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 499 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 499 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 57 affected / 499 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Intracardiac mass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Tricuspid valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Ventricular tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 499 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 499 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 499 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 499 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 499 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 499 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 499 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device connection issue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Implant site oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Implant site erythema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 499 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 499 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 499 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 499 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 499 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 499 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 499 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Medication error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Twiddler s syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 499 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 499 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 499 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 499 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 499 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Pituitary tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 499 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Myelitis transverse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 499 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 499 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 499 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 499 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 499 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 499 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 499 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 499 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 499 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 499 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 499 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dry gangrene
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Arterial haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 499 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 499 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Cardiac sarcoidosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 499 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular dyssynchrony
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 499 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 499 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 499 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 499 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 499 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 499 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device alarm issue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Implant site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Implant site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: General disorders
Frequency: 11 affected / 499 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 499 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 499 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Oversensing
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Phantom shocks
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Undersensing
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Implant site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac vein perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 499 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 499 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Carotid artery occlusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Thrombotic stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 499 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 499 at risk

Adverse event: Cheyne-Stokes respiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dyspnoea paroxysmal nocturnal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 499 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 499 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 499 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 499 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Superior vena cava stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 499 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Cardiomyopathy alcoholic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 326 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 326 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cardiorenal syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 326 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 326 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 326 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Barrett s esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Gastric fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Intestinal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Salivary gland cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 326 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device connection issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 326 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 326 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 326 at risk

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 326 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 326 at risk

Adverse event: Phantom shocks
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Undersensing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 326 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 326 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 326 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Foreign body in gastrointestinal tract
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Anticoagulation drug level below therapeutic
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 326 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 326 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 326 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 326 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 326 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 326 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Arteriovenous fistula operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 326 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 326 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 326 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 326 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 326 at risk

Adverse event: Device physical property issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 326 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Implant site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: General disorders
Frequency: 5 affected / 326 at risk

Adverse event: Implant site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Implant site hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 326 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 326 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 326 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 326 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Anaemia postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 326 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 326 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 300 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Ventricular flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 300 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 300 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Device connection issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 300 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 300 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Abscess jaw
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 300 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Alpha haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Twiddler s syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 300 at risk

Adverse event: Coagulation test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Myasthenia gravis crisis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 300 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 300 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 300 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 300 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 300 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ovarian mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 300 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pulmonary toxicity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Enterostomy closure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 300 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Bleeding varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 300 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 300 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 300 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 300 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 300 at risk

Adverse event: Device connection issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Device dislocation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 300 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 300 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 300 at risk

Adverse event: Oversensing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 300 at risk

Adverse event: Medical device site erosion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 300 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Nephrosclerosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hydrothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Bleeding varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Circulatory collapse
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 300 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 300 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk