Study: NCT02832622

Adverse event: Abnormal Labs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Aortic Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 2169 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 72 affected / 2169 at risk

Adverse event: Cardiac sarcoidosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Carotid Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 2169 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 168 affected / 2169 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2169 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Non-St-Elevation Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 2169 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Valve Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Abnormal Labs
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Gallstone
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 2169 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Peritonits
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Abnormal Labs
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 2169 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 2169 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 2169 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Device Discharge
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 2169 at risk

Adverse event: Hematoma/Seroma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Hepato-Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Medication error
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Metabolic Bone Disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Non-Cardiac Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 2169 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 2169 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Unresponsiveness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Acute Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2169 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 80 affected / 2169 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 2169 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 2169 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2169 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 2169 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2169 at risk

Adverse event: Cardiac/Coronary Sinus Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac/Coronary Sinus Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2169 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Hematoma/Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 2169 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2169 at risk

Adverse event: Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Pneumothorax/Hemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2169 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Renal Failure From Contrast Media Used To Visualize Coronary Veins
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Thrombolytic or Air Embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Wound Site Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Abnormal Labs
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 2169 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Induced Atrial or Ventricular Arrhythmias
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Rise in Threshold and Exit Block
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Colon Polyps
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2169 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 2169 at risk

Adverse event: Cerebellar haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac/Coronary Sinus Perforation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Change in Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2169 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Elevated Defibrillation Threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Induced Atrial or Ventricular Arrhythmias
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Infection
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 35 affected / 2169 at risk

Adverse event: Lead/Port Damage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2169 at risk

Adverse event: Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 2169 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Rise in Threshold And Exit Block
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dialysis Shunt Occlusion
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 2169 at risk

Adverse event: Renal Transplantation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 2169 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 2169 at risk

Adverse event: Wound Site Complications
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2169 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2169 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Carotid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Occluded Stent
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Peripheral Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Ruptured Abdominal Aortic Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 2169 at risk

Adverse event: Thrombolytic or Air Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Thrombolytic or Air Embolism
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Cardiac Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 2169 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Heart Failure Exacerbation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 2169 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Change in Thresholds
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Device issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hematoma/Seroma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2169 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2169 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 2169 at risk

Adverse event: Loss Of CapturePectoral/Diaphragmatic/Phrenic Nerve Stimulation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 2169 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2169 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2169 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Anaemia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Cardiac/Coronary Sinus Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2169 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Excessive Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2169 at risk

Adverse event: Hematoma/Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 2169 at risk

Adverse event: Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2169 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2169 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Thrombolytic or Air Embolism
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2169 at risk

Adverse event: Wound Site Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2169 at risk

Adverse event: Increased Impedance
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Induced Atrial or Ventricular Arrhythmias
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2169 at risk

Adverse event: Change in Thresholds
Serious: no
Organ System: Product Issues
Frequency: 22 affected / 2169 at risk

Adverse event: Device Discharge
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Inappropriate Therapy
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2169 at risk

Adverse event: Induced Atrial or Ventricular Arrhythmias
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Product Issues
Frequency: 32 affected / 2169 at risk

Adverse event: Lead/Port Damage
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 12 affected / 2169 at risk

Adverse event: Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 2169 at risk

Adverse event: LV Lead Stylet Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
Serious: no
Organ System: Product Issues
Frequency: 104 affected / 2169 at risk

Adverse event: Rise in Threshold and Exit Block
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2169 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2169 at risk