Study: NCT02787785

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Heart Failure Symptoms, unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pseudoaneurysm without hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 11 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chest Pain - other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Physican Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Inappropriate tachy therapy
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 29 at risk

Adverse event: Incisional/Superficial infections (</= 30 days post implant without explant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Hematoma - Device pocket (> 30 days post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Device System Discomfort (> 30 days post implant)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 29 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pulmonary Edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Heart Failure Symptoms, unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 29 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk

Adverse event: Chest Pain- Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Subject Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cerebrovascular Accident (CVA) - unspecified
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Death, unknown cause
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 29 at risk

Adverse event: Fever and or virus
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 29 at risk

Adverse event: Inappropriate tachy therapy, noise
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 29 at risk

Adverse event: Inappropriate therapy - SVT discrimination error - System
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 29 at risk

Adverse event: Inadvertent Arrhythmia - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 29 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Chest Pain - other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Physican Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 29 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk