Study: NCT03719040

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 870 at risk

Adverse event: Exacerbation Of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 870 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 870 at risk

Adverse event: Atrial Extrasystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Nonsustained Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Premature Atrial Complex
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Rapid Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 870 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 870 at risk

Adverse event: Intestinal Lesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 870 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 870 at risk

Adverse event: Decrease In General State Of Health
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 870 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Bed Rest Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Exacerbation Of Heart Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Falls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 870 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 870 at risk

Adverse event: Covid 19 Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 870 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 870 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 870 at risk

Adverse event: Lower Leg Swelling
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 870 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 870 at risk

Adverse event: Worsening Mitral Regurgitation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 870 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 870 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 870 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 870 at risk

Adverse event: Atypical fibroxanthoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 870 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 870 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 870 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 870 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 870 at risk

Adverse event: Lead Migration/Dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 12 affected / 870 at risk

Adverse event: Rise In Threshold/Elevated Pacing Threshold
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 870 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Lead Malfunction Due To Conductor Fracture/Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Loss Of Normal Device Function Due To Battery Failure Or Component Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Possible Post Traumatic Stress Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 870 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 870 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 870 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 870 at risk

Adverse event: Atrioventricular block complete
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Pacemaker-Mediated Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 870 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 870 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Left Upper Extremity Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 870 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 870 at risk

Adverse event: Hematoma/Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 870 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Chest pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Incision Site Dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Lead Migration/Dislodgement
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Swelling At Incision Site And Left Arm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Thromboemboli
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 870 at risk

Adverse event: Hematoma/Seroma
Serious: no
Organ System: Investigations
Frequency: 1 affected / 870 at risk

Adverse event: Lead Migration/Dislodgement
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 870 at risk

Adverse event: Rise In Threshold/Elevated Pacing Threshold
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 870 at risk

Adverse event: Loss Of Pacing And/Or Sensing
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 870 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 870 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 870 at risk

Adverse event: Interruption Of Desired Pulse Generator Function Due To Electrical Interference
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Lead Malfunction Due To Conductor Fracture/Lead Fracture
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 870 at risk

Adverse event: Left Upper Extremity Edema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 870 at risk