Study: NCT03075215

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 2015 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Arrhythmia-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 2015 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 2015 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 2015 at risk

Adverse event: Cardiac Medication Complication - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 2015 at risk

Adverse event: Chest Pain - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 2015 at risk

Adverse event: Gastrointestinal - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Heart Failure Patient Condition - Cardiovascular - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 2015 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 63 affected / 2015 at risk

Adverse event: Hypotension - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Incessant VT/ VT Storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Multi-system Failure - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 84 affected / 2015 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2015 at risk

Adverse event: Patient Condition - Cardiovascular - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2015 at risk

Adverse event: Pericardial effusion - unrelated procedure/device
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Peripheral edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Pleural Effusion - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Pulmonary Edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Pulseless Electrical Activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Renal Failure/Insufficiency - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Syncope - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Valvular Damage/Valvular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 2015 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 2015 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 8 affected / 2015 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 2015 at risk

Adverse event: Adverse Reaction - Medication
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 2015 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 34 affected / 2015 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 2015 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Patient Condition - Non-Cardiovascular - OTHER
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 2015 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2015 at risk

Adverse event: Infection (> 30 days post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 2015 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 2015 at risk

Adverse event: System Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 2015 at risk

Adverse event: Hematoma - pocket (≤ 30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2015 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2015 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2015 at risk

Adverse event: Post -Surgical infection (≤ 30 days post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2015 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Procedure - PG System - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Unrelated procedure/device - OTHER
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 2015 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 2015 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 2015 at risk

Adverse event: Conductor Coil Fracture - RA
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Conductor Coil Fracture - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Elevated Threshold - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Elevated threshold - LV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Dislodgement - Elevated threshold - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Extracardiac stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Dislodgement - Extracardiac stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Multiple signs - LV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Dislodgement - Multiple signs - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Dislodgement - Multiple signs- RA
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Dislodgement - No reported signs - LV
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 2015 at risk

Adverse event: Dislodgement - No reported signs - RA
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 2015 at risk

Adverse event: Dislodgement - No reported signs - RV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 2015 at risk

Adverse event: Dislodgement - Unable to Capture - LV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Dislodgement - Unable to capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 2015 at risk

Adverse event: Electrode Damaged - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Elevated Threshold - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Elevated Threshold - RA
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 2015 at risk

Adverse event: Extracardiac Stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 2015 at risk

Adverse event: Helix damaged - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: High Out of Range Impedance - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Impedance Out of Range
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Inappropriate Tachy Therapy - SVT
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Other Lead Related
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: PG System diagnosis - OTHER
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: PG System - Patient Related - OTHER
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2015 at risk

Adverse event: Unable to Capture - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Unable to Capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Unable to Capture - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 2015 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 30 affected / 2015 at risk

Adverse event: Adverse Reaction - Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Pleural Effusion - unrelated procedure/device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Pneumothorax - unrelated procedure/device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 2015 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Skin burns
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Cerebrovascular accident (CVA) - ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 2015 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2015 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 2015 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 2015 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 2015 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Atrial (Type I) Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 2015 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Dyspnea - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 2015 at risk

Adverse event: Heart Failure Patient Condition - Cardiovascular - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 2015 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 2015 at risk

Adverse event: Patient Condition - Cardiovascular - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Pericardial Effusion - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Peripheral edema - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Torsade de pointes
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 2015 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 2015 at risk

Adverse event: Chest Pain - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2015 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2015 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Infection (> 30 days post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2015 at risk

Adverse event: System Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2015 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2015 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2015 at risk

Adverse event: Conductor Coil Fracture - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Elevated threshold - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Dislodgement - Multiple signs - LV
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2015 at risk

Adverse event: Dislodgement - No reported signs - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Elevated Threshold - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Elevated Threshold - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Extracardiac Stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 20 affected / 2015 at risk

Adverse event: Inappropriate Tachy Therapy - SVT
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 2015 at risk

Adverse event: Inappropriate tachy therapy - NSR
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2015 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Other - PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2015 at risk

Adverse event: Pacemaker Mediated Tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 2015 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2015 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2015 at risk