Study: NCT03089281

Adverse event: Infection > 30 Days Post-Implant (Pulse Generator-related)
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 225 at risk

Adverse event: Dislodgment (Right Ventricular Lead-Related)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Dislodgment (Left Ventricular Lead-Related)
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 225 at risk

Adverse event: Post-Surgical Infection (<=30 Days Post-Implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Hematoma - Pocket (<=30 Days Post-Implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 225 at risk

Adverse event: Thromboembolic Events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 225 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 225 at risk

Adverse event: Ventricular Tachycardia/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 225 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 225 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Adverse Reaction - General
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Adverse reaction - Allergic Reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 225 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 225 at risk

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Neurological
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 225 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 225 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 225 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 225 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 225 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 225 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 225 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 225 at risk

Adverse event: Inappropriate Tachy Therapy (Pulse Generator-Related)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 225 at risk

Adverse event: Fatigue (Pulse Generator-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Dislodgment (Right Atrial Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Extracardiac Stimulation (Right Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Unable to Capture (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 225 at risk

Adverse event: Extracardiac Stimulation (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 225 at risk

Adverse event: Perforation at Implant (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Dislodgment (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 225 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 225 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 225 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 225 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Atrial Tachycardia / Other Supraventricular Tachycardia (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Unable to Capture (Right Atrial Lead-related)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Dislodgment (Right Atrial Lead-Related)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Dislodgment (Left Ventricular Lead-Related)
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 215 at risk

Adverse event: Post-Surgical Wound Discomfort/Bruising/Swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Post-Surgical Infection (<=30 Days Post-Implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 215 at risk

Adverse event: Adverse Reaction - General
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 215 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Ventricular Tachycardia/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Valvular Damage/Valvular Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Adverse reaction - Medication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Fever/Virus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 215 at risk

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Neurological
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 215 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 215 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 215 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 215 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 215 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 215 at risk

Adverse event: Oversensing (Pulse Generator-related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Inappropriate Tachy Therapy (Pulse Generator-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Dislodgment (Right Atrial Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Dislodgment (Right Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Inappropriate Tachy Therapy (Right Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 215 at risk

Adverse event: Unable to Capture (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 215 at risk

Adverse event: Extracardiac Stimulation (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 215 at risk

Adverse event: Dislodgment (Left Ventricular Lead-Related)
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 215 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 215 at risk

Adverse event: Lower Extremity Edema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 215 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Fatigue / Weakness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk