Study: NCT02166606

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 14 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Death
Frequency: 13 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Cancer
Frequency: 10 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary
Frequency: 10 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Physical trauma
Frequency: 7 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Renal and urinary disorders
Notes: Genitourinary
Frequency: 6 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological
Frequency: 6 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Other - Subject condition - Non- cardiovascular
Frequency: 6 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal
Frequency: 5 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal
Frequency: 5 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Endocrine disorders
Notes: Endocrine
Frequency: 4 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Head, eyes, ears, nose, throat
Frequency: 4 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Fever
Frequency: 3 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Integumentary
Frequency: 3 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Infections and infestations
Notes: Systemic infection
Frequency: 3 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hematological
Frequency: 2 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Abnormal laboratory values
Frequency: 1 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: General disorders
Notes: Adverse reaction - General
Frequency: 1 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychological
Frequency: 1 affected / 1174 at risk

Adverse event: Non-Cardiovascular/General
Serious: yes
Organ System: Nervous system disorders
Notes: Vasovagal reaction
Frequency: 1 affected / 1174 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial fibrillation
Frequency: 12 affected / 1174 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Other Supra Ventricular Tachycardia (SVT)
Frequency: 8 affected / 1174 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial flutter
Frequency: 6 affected / 1174 at risk

Adverse event: Related to Ischemia
Serious: yes
Organ System: Cardiac disorders
Notes: Coronary artery disease
Frequency: 12 affected / 1174 at risk

Adverse event: Related to Ischemia
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial infarction
Frequency: 3 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: General disorders
Notes: Dizziness
Frequency: 4 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chest pain - Other
Frequency: 3 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain - Ischemic
Frequency: 2 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 2 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: General disorders
Notes: Multiple symptoms
Frequency: 1 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: Cardiac disorders
Notes: Other - Subject condition - Cardiovascular
Frequency: 1 affected / 1174 at risk

Adverse event: Symptoms (Non-Heart Failure Related)
Serious: yes
Organ System: General disorders
Notes: Syncope
Frequency: 1 affected / 1174 at risk

Adverse event: Related to Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure symptoms - Unspecified
Frequency: 7 affected / 1174 at risk

Adverse event: Related to Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Dyspnea - Heart failure
Frequency: 3 affected / 1174 at risk

Adverse event: Related to Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Other- Heart failure subject condition - Cardiovascular
Frequency: 3 affected / 1174 at risk

Adverse event: Related to Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Hypertension - Heart failure
Frequency: 1 affected / 1174 at risk

Adverse event: Related to Blood Pressure
Serious: yes
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 3 affected / 1174 at risk

Adverse event: Related to Blood Pressure
Serious: yes
Organ System: Vascular disorders
Notes: Cardiogenic shock
Frequency: 1 affected / 1174 at risk

Adverse event: Related to Blood Pressure
Serious: yes
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 1 affected / 1174 at risk

Adverse event: Related to Vasculature
Serious: yes
Organ System: Vascular disorders
Notes: Peripheral vascular disease
Frequency: 5 affected / 1174 at risk

Adverse event: Ventricular Tachyarrythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular tachycardia
Frequency: 3 affected / 1174 at risk

Adverse event: Ventricular Tachyarrythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Nonsustained ventricular tachycardia
Frequency: 1 affected / 1174 at risk

Adverse event: Thromboembolic Events
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Cerebrovascular accident
Frequency: 2 affected / 1174 at risk

Adverse event: Thromboembolic Events
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pulmonary embolism
Frequency: 2 affected / 1174 at risk

Adverse event: Other (Unrelated to Procedure/Device)
Serious: yes
Organ System: Infections and infestations
Notes: Pericarditis - Unrelated to procedure or device
Frequency: 1 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Dislodgment - No reported signs - RA
Frequency: 9 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Other - Lead
Frequency: 2 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Dislodgment - Elevated threshold - RA
Frequency: 1 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Elevated threshold - RA
Frequency: 1 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Impedance \> 2000 ohms - RA
Frequency: 1 affected / 1174 at risk

Adverse event: Right Atrium - Brady
Serious: yes
Organ System: Product Issues
Notes: Other - Pulse Generator (PG) system
Frequency: 1 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Dislodgment - No reported signs - RV
Frequency: 6 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Myocardial perforation post-implant - RV
Frequency: 2 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Unable to capture - RV
Frequency: 2 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Conductor coil fracture - RV
Frequency: 1 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Dislodgment - Multiple signs - RV
Frequency: 1 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Dislodgment - Unable to capture - RV
Frequency: 1 affected / 1174 at risk

Adverse event: Right Ventricle - Brady
Serious: yes
Organ System: Product Issues
Notes: Elevated threshold - RV
Frequency: 1 affected / 1174 at risk

Adverse event: Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pneumothorax
Frequency: 6 affected / 1174 at risk

Adverse event: Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hemothorax
Frequency: 2 affected / 1174 at risk

Adverse event: Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Other - Lead - Procedure
Frequency: 1 affected / 1174 at risk

Adverse event: Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pericardial effusion
Frequency: 1 affected / 1174 at risk

Adverse event: PG System - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hematoma - Pocket (≤ 30 days post-implant)
Frequency: 2 affected / 1174 at risk

Adverse event: PG System - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Other - PG system - Procedure
Frequency: 1 affected / 1174 at risk

Adverse event: PG system - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-surgical pocket hemorrhage
Frequency: 1 affected / 1174 at risk

Adverse event: Device Deficiency
Serious: yes
Organ System: Product Issues
Notes: Device Deficiency
Frequency: 3 affected / 1174 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: yes
Organ System: Product Issues
Notes: Other SVT (e.g. AVRT, AVNRT, EAT)
Frequency: 2 affected / 1174 at risk

Adverse event: PG System - Subject
Serious: yes
Organ System: Infections and infestations
Notes: Infection (\> 30 days post-implant)
Frequency: 1 affected / 1174 at risk

Adverse event: PG System - Therapy
Serious: yes
Organ System: Product Issues
Notes: Pacemaker-mediated tachycardia
Frequency: 1 affected / 1174 at risk

Adverse event: Ventricular Tachyarrythmias
Serious: yes
Organ System: Cardiac disorders
Notes: Torsades des pointes
Frequency: 1 affected / 1174 at risk