Study: NCT03257436

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 584 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 584 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 584 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 584 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 584 at risk

Adverse event: Gastrointestinal - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 584 at risk

Adverse event: Incessant VT/VT Storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Multiple Ventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 584 at risk

Adverse event: Other - Heart failure patient condition- Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 584 at risk

Adverse event: Other - Patient condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Pericardial effusion - Unrelated (non study) procedure or device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 584 at risk

Adverse event: Renal insufficiency/failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Valvular damage/Valvular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 584 at risk

Adverse event: Weight gain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Atrial (Type 1) Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 584 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 584 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 584 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 584 at risk

Adverse event: Fatigue and Weakness
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 584 at risk

Adverse event: HEENT
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 584 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 584 at risk

Adverse event: Other-Patient Condition-Non-Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 584 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 584 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 584 at risk

Adverse event: Infection (>30 days post-implant) - PG System - Subject related
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 584 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 584 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 584 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 584 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 584 at risk

Adverse event: Seroma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 584 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 584 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 584 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 584 at risk

Adverse event: Dislodgement - LV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 584 at risk

Adverse event: Dislodgement - RA
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 584 at risk

Adverse event: Dislodgement - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 584 at risk

Adverse event: Erosion - PG System - Subject related
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Inappropriate Tachy Therapy - SVT - PG System Therapy
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Inappropriate tachy therapy - SVT - Defibrillation lead
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 584 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 584 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 584 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 584 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 584 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 584 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 584 at risk

Adverse event: Cerebrovascular Accident (CVA) - unspecifed
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 584 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 584 at risk

Adverse event: Hematoma - Unrelated (non study) procedure or device
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Myocardial Infacrtion
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 584 at risk

Adverse event: Pseudoaneurysm with hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 584 at risk

Adverse event: Premature Atrial Contraction (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 584 at risk

Adverse event: Weight gain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 584 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 584 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Adverse reaction - Medication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Other - Patient condition- Non-cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 584 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 584 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 584 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 584 at risk

Adverse event: Post-surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 584 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 584 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 584 at risk

Adverse event: Dislodgment - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Elevated threshold - LV Lead
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 584 at risk

Adverse event: Extracardiac stimulation - LV Lead
Serious: no
Organ System: Product Issues
Frequency: 21 affected / 584 at risk

Adverse event: Extracardiac stimulation - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Inappropriate tachy therapy - NSR -Defibrillation lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Inappropriate tachy therapy - SVT - Defibrillation lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 584 at risk

Adverse event: Pacemaker Mediated Tachycardia - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 584 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 584 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 584 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 584 at risk

Adverse event: Arterial/venous thrombolytic event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 584 at risk