Study: NCT02923726

Adverse event: Impedance Out of Range - RV PG System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Undersensing - Defibrillation - PG System
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Elevated DFT - Defibrillation - PG System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Inappropriate Tachy Therapy - SVT - PG System Therapy
Serious: yes
Organ System: Product Issues
Frequency: 13 affected / 1302 at risk

Adverse event: Infection (>30 days post-implant) - PG System - Subject related
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1302 at risk

Adverse event: Twiddler's Syndrome - PG System - Subject related
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Migration - PG System - Subject related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1302 at risk

Adverse event: Post-surgical wound discomfort/bruising/swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1302 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1302 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Death-Unknown - PG System - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Deep Vein Thrombosis - PG System - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Conductor coil fracture - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - Multiple signs - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - No reported signs - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Thrombosis - Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Tricuspid Valve Damage RV lead - Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Extracardiac stimulation - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Conductor coil fracture - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Myocardial perforation post-implant - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Dislodgment - Elevated threshold -RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Dislodgment - Multiple signs - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - No reported signs - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Pericardial effusion - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 1302 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 1302 at risk

Adverse event: Nonsustained Ventricular Tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 1302 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1302 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1302 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1302 at risk

Adverse event: VF with Syncope - Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: VT with Syncope - Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1302 at risk

Adverse event: Syncope - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1302 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 1302 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1302 at risk

Adverse event: Renal insufficiency/failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Dehydration - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Hypotension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Pleural Effusion - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Cardiac medication complication - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 1302 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 171 affected / 1302 at risk

Adverse event: Heart transplant - Heart Failure Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1302 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1302 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1302 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1302 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 31 affected / 1302 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 1302 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1302 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1302 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Valvular damage/Valvular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 1302 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1302 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 1302 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 1302 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1302 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1302 at risk

Adverse event: Abdominal Aortic Aneurysm - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Cardiac Sarcoidosis - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Internal Carotid Artery (ICA) - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Cerebrovascular Accident (CVA) - unspecifed
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 1302 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1302 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1302 at risk

Adverse event: Arterial/venous thrombolytic event
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Cerebrovascular Accident (CVA) - ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1302 at risk

Adverse event: Cerebrovascular Accident (CVA) - hemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Pericardial effusion - Unrelated (non study) procedure or device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Hematoma - Unrelated (non study) procedure or device
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Pneumothorax - Unrelated (non study) procedure or device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Infection - Unrelated (non study) procedure or device
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1302 at risk

Adverse event: Pleural Effusion - Unrelated (non study) procedure or device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1302 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1302 at risk

Adverse event: Adverse reaction - Medication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Alcohol Dependency - Patient Condition - Non-Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1302 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 46 affected / 1302 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1302 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1302 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1302 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 1302 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 1302 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 1302 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 1302 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 1302 at risk

Adverse event: Obesity - Whole Body
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Sternal Wire Protrusion s/p CABG repair - Whole Body
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 1302 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 34 affected / 1302 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 1302 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 1302 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 1302 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1302 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 10 affected / 1302 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 50 affected / 1302 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1302 at risk

Adverse event: Oversensing - RA PG System
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Undersensing - RA PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Oversensing - RV PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Impedance Out of Range - RV PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Oversensing - Defibrillation - PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Inappropriate Tachy Therapy - SVT - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 20 affected / 1302 at risk

Adverse event: Early ERI - Premature declaration - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Pacemaker Mediated Tachycardia - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Twiddler's Syndrome - PG System - Subject related
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Migration - PG System - Subject related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Complex Regional Pain Syndrome and Frozen Shoulder - PG System - Patient Related
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Post-surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1302 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1302 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1302 at risk

Adverse event: Unable to capture - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Elevated threshold - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - Multiple signs - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - No reported signs - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Conductor coil fracture - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - Elevated threshold -RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Dislodgment - No reported signs - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1302 at risk

Adverse event: Impedance Out of Range - Defibrillation lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1302 at risk

Adverse event: Pericardial effusion - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1302 at risk

Adverse event: 3rd degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 1302 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 93 affected / 1302 at risk

Adverse event: Nonsustained Ventricular Tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 153 affected / 1302 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 100 affected / 1302 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 1302 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 67 affected / 1302 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Arrhythmia Not Specified - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Prolonged Q-T Interval - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: VF with Syncope - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: VT with Syncope - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1302 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1302 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1302 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 1302 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 1302 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 20 affected / 1302 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 1302 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 1302 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Arterial/venous thrombolytic event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Hematoma - Unrelated (non study) procedure or device
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Hemorrhage - Unrelated (non study) procedure or device
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Infection - Unrelated (non study) procedure or device
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1302 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Adverse reaction - Medication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Abdominal Pain - Patient Condition - Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1302 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1302 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 1302 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1302 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1302 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 1302 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1302 at risk

Adverse event: Unable to capture - RA PG System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Elevated threshold - RV PG System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Inappropriate Tachy Therapy - SVT - PG System Therapy
Serious: yes
Organ System: Product Issues
Frequency: 17 affected / 1293 at risk

Adverse event: Infection (>30 days post-implant) - PG System - Subject related
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1293 at risk

Adverse event: Post-surgical wound discomfort/bruising/swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1293 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Unable to capture - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Myocardial perforation post-implant - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Unable to capture - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Conductor coil fracture - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Myocardial perforation post-implant - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1293 at risk

Adverse event: Dislodgment - Unable to capture - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1293 at risk

Adverse event: Dislodgment - Elevated threshold -RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1293 at risk

Adverse event: Dislodgment - Oversensing - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - Multiple signs - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - No reported signs - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Impedance Out of Range - Defibrillation lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Pericardial effusion - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1293 at risk

Adverse event: 3rd degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Pulseless Electrical Activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 1293 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 1293 at risk

Adverse event: Nonsustained Ventricular Tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 68 affected / 1293 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1293 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1293 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1293 at risk

Adverse event: SVT vs VT - Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: VT with Syncope - Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1293 at risk

Adverse event: Syncope - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Dizziness - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1293 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 1293 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1293 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Fatigue - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Renal insufficiency/failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Gastrointestinal - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Hypotension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Pleural Effusion - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1293 at risk

Adverse event: Cardiac medication complication - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 1293 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 160 affected / 1293 at risk

Adverse event: Hypertension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 1293 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1293 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1293 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 1293 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 1293 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 1293 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1293 at risk

Adverse event: Valvular damage/Valvular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 1293 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 1293 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 1293 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1293 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 1293 at risk

Adverse event: Abdominal Aortic Aneurysm - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1293 at risk

Adverse event: Amyloidosis - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Aortic Abdominal Aneurysm - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Cardiac Sarcoidosis - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Thoracic Aortic Aneurysm - Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Cerebrovascular Accident (CVA) - unspecifed
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 1293 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1293 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Arterial/venous thrombolytic event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Cerebrovascular Accident (CVA) - ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 1293 at risk

Adverse event: Cerebrovascular Accident (CVA) - hemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Pericardial effusion - Unrelated (non study) procedure or device
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Pericarditis - Unrelated (non study) procedure or device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Hemorrhage - Unrelated (non study) procedure or device
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Pneumothorax - Unrelated (non study) procedure or device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Infection - Unrelated (non study) procedure or device
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1293 at risk

Adverse event: Pleural Effusion - Unrelated (non study) procedure or device
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Adverse reaction - Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 1293 at risk

Adverse event: General Discomfort - Patient Condition - Non-Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 1293 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 38 affected / 1293 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1293 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1293 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1293 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1293 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 1293 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 21 affected / 1293 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 1293 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 1293 at risk

Adverse event: Abominal Pseudoanerysm with active extravasion - Whole Body
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: PICC Line Malfunction - Whole Body
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 23 affected / 1293 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 47 affected / 1293 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 1293 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 1293 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 1293 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1293 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 15 affected / 1293 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 33 affected / 1293 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1293 at risk

Adverse event: Oversensing - RA PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Inappropriate Tachy Therapy - SVT - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 40 affected / 1293 at risk

Adverse event: Pacemaker Mediated Tachycardia - PG System Therapy
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 1293 at risk

Adverse event: Inadequate healing of incision site - PG System - Subject related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Psychological effect due to device therapy - PG System - Subject related
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Migration - PG System - Subject related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Pain at Site - PG System - Patient Related
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Post-surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1293 at risk

Adverse event: Post-surgical infection (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1293 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1293 at risk

Adverse event: Oversensing - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1293 at risk

Adverse event: Undersensing - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Unable to capture - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Extracardiac stimulation - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Conductor coil fracture - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - Elevated threshold - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - No reported signs - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Oversensing - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Elevated threshold - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Extracardiac stimulation - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Insulation breach - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - Unable to capture - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Dislodgment - Elevated threshold -RV Lead
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1293 at risk

Adverse event: Dislodgment - Undersensing - RV Lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Impedance Out of Range - Defibrillation lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1293 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Attempted coronary sinus lead placement - Lead - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 1293 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 117 affected / 1293 at risk

Adverse event: Nonsustained Ventricular Tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 150 affected / 1293 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 96 affected / 1293 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 1293 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 53 affected / 1293 at risk

Adverse event: Junctional ectopic rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Intraventricular Conduction Disorder - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Tachycardia patient reported - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: VF with Syncope - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: VT with Syncope - Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1293 at risk

Adverse event: Dizziness - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1293 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Renal insufficiency/failure - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Dehydration - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 1293 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 1293 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1293 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 17 affected / 1293 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 1293 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1293 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1293 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Pericarditis - Unrelated (non study) procedure or device
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Puncture Site Ulcer - Unrelated Procedure/Device
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1293 at risk

Adverse event: Adverse reaction - Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Dehydration - Patient Condition - Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1293 at risk

Adverse event: Fever and/or Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1293 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1293 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1293 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1293 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1293 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1293 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1293 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1293 at risk