Study: NCT03185832

Adverse event: Infection (> 30 days post implant)
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 239 at risk

Adverse event: Hematoma- Pocket (>30 days post implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 239 at risk

Adverse event: Elevated Threshold - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 171 at risk

Adverse event: Elevated Threshold - LV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 115 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 239 at risk

Adverse event: Post -Surgical infection (<= 30 days post implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 239 at risk

Adverse event: Hematoma - pocket (<= 30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 239 at risk

Adverse event: Syncope - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dizziness - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Chest Pain - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 354 at risk

Adverse event: Peripheral edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Fatigue - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 354 at risk

Adverse event: Renal Failure/Insufficiency - Heart Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 354 at risk

Adverse event: Dehydration - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Weight Gain - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 354 at risk

Adverse event: Pleural Effusion - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Cardiac Medication Complication - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 354 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 354 at risk

Adverse event: Other - Heart failure patient condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 354 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 354 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 354 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 354 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 354 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 354 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 354 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 354 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 354 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Other - Patient condition
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 354 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 354 at risk

Adverse event: Cerebrovascular accident (CVA) - ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Pneumothorax - unrelated procedure/device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Other - Unrelated to procedure/device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Adverse Reaction - Medication
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 354 at risk

Adverse event: Other - Patient condition
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 354 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 354 at risk

Adverse event: System Infection
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 354 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 354 at risk

Adverse event: Localised infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 354 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 354 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 354 at risk

Adverse event: Other - Whole body
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 354 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 354 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 354 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 354 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 354 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 354 at risk

Adverse event: Incisional/Superficial Infection (<= 30d post implant without explant)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 16 at risk

Adverse event: Extracardiac Stimulation - LV PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 239 at risk

Adverse event: Inappropriate tachy therapy - SVT - Defibrillation Lead
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 171 at risk

Adverse event: Extracardiac Stimulation - LV Lead
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 115 at risk

Adverse event: Hematoma - pocket (<= 30 days post-implant)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 239 at risk

Adverse event: Dizziness - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Chest Pain - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dyspnea - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 354 at risk

Adverse event: Renal Failure/Insufficiency - Heart Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dehydration - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 354 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 354 at risk

Adverse event: Other - Heart failure patient condition
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 354 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 354 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 354 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 354 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 354 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 354 at risk

Adverse event: Other - Patient condition
Serious: no
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Hemorrhage - unrelated procedure/device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Pleural Effusion - unrelated procedure/device
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 354 at risk

Adverse event: Adverse Reaction - Medication
Serious: no
Organ System: General disorders
Frequency: 2 affected / 354 at risk

Adverse event: System Infection
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 354 at risk

Adverse event: Fever and/or Virus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 354 at risk

Adverse event: Physical Trauma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 354 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 354 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 354 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 354 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 354 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 354 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 354 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 354 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 354 at risk

Adverse event: Inappropriate Tachy Therapy - Other - PG
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 16 at risk