Study: NCT04732728

Adverse event: 1st Degree AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 727 at risk

Adverse event: 2nd Degree AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: 3rd Degree AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 727 at risk

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 727 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 727 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 727 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 727 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 727 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 727 at risk

Adverse event: Cerebrovascular accident (CVA) - ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 727 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 727 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 727 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 727 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 727 at risk

Adverse event: Dehydration - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 727 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 727 at risk

Adverse event: Oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 727 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 727 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 727 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 727 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 727 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 727 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 727 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 727 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 727 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 727 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 727 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 727 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 727 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 727 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Pericardial effusion - unrelated procedure/device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 727 at risk

Adverse event: Pleural Effusion - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Pneumothorax - unrelated procedure/device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 727 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 718 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 727 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 727 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 727 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 727 at risk

Adverse event: System Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 727 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 727 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Dislodgement - Unable to capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 727 at risk

Adverse event: 2nd Degree AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: 3rd Degree AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 727 at risk

Adverse event: Adverse Reaction - other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 718 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 48 affected / 727 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 727 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 727 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 727 at risk

Adverse event: Chest Pain - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Chest Pain - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 727 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 727 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 727 at risk

Adverse event: Dyspnea - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 727 at risk

Adverse event: Erosion
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 718 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 727 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 727 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 727 at risk

Adverse event: Infection (> 30 days post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 718 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 727 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 727 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 727 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 727 at risk

Adverse event: Other - ICM System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 718 at risk

Adverse event: PG System - Patient Related - OTHER
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 718 at risk

Adverse event: Patient Condition - Cardiovascular - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 727 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 727 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 718 at risk

Adverse event: Post -Surgical infection ( 30 days post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 718 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 718 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 727 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 727 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 727 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 10 affected / 727 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 727 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 727 at risk

Adverse event: Whole Body - OTHER
Serious: no
Organ System: General disorders
Frequency: 2 affected / 727 at risk

Adverse event: Device expulsion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 718 at risk