Study: NCT02097290

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 210 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Adverse Reaction - Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Adverse Reaction - Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Arterial/Venous Trombolytic Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Atrial Fibrillation (Af)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 210 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 210 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 210 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 210 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cerebrovascular Accident (Cva)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Coronary Venous Perforation Without Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment - Elevated Threshold - Rv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment - Extracardiac Stimulation - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment - Multiple Signs - Rv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment - No Reported Signs - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Dislodgment - No Reported Signs - Ra
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment - Unable To Capture - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Dislodgment - Unable To Capture - Ra
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 210 at risk

Adverse event: Elevated Threshold - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 210 at risk

Adverse event: Extracardiac Stimulation - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 210 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Gastrointestinal - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 210 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 210 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 210 at risk

Adverse event: Hematoma - Pocket (<=30 Days Post-Implant)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hypotension - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Impedance < 300 Ohms - Ra
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Inadvertent Vt/Vf
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Inappropriate Tachy Therapy - Svt
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Infection (> 3 Days Post-Implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Migration
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 210 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Multi-System Failure - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 210 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 210 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 210 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 210 at risk

Adverse event: Myocardial Perforation Post-Implant - Rv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Myocardial Perforation With Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 210 at risk

Adverse event: Other-Lead-Procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Peripheral Edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 210 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 210 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 210 at risk

Adverse event: Post-Surgical Wound Discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 210 at risk

Adverse event: Premature Ventricular Contractions (Pvc)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pulmonary Edema - Heart Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 210 at risk

Adverse event: Renal Failure Due To Contrast Media - Procedure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Renal Insufficiency - Heart Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 210 at risk

Adverse event: Unable To Capture - Lv
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Unable To Convert - Defibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ventricular Fibrillation (Vf)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Ventricular flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ventricular Tachycardia (Vt)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Failure To Implant Epicardial Lv Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Inability To Place The Lv Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Left Chest Wall Emphysema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Left Leg Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: ICD shocks
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Severe Rt. Leg Stump Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Unable To Insert Lv Lead With Initial Procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vestibulitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 210 at risk

Adverse event: Angioedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Patient Death - unknown cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Abnormal Laboratory Values
Serious: no
Organ System: General disorders
Frequency: 7 affected / 210 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Delirium
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 210 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Atrial Tachyarrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 210 at risk

Adverse event: Unable to perform Threshold test-RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Chest Pain-Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Chest Pain-Other
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 210 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Coronary Venous Dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Dislodgment-extracardiac stimulation-RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment-LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment-unable to capture-LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dislodgment-unable to capture-RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 210 at risk

Adverse event: Dyspnea-heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 210 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 210 at risk

Adverse event: Extracardiac stimulation-LV
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 210 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 210 at risk

Adverse event: Genitorurinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 210 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 210 at risk

Adverse event: Hematoma (less than 30 days post implant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 210 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Immune disorder
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Insulation breach-RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 210 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 210 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 210 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Nonsustained Ventricular Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Other PG-system-procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiovascular event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Oversensing-RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 210 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Peripheral edema-heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: PG system-event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Physical Trauma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 210 at risk

Adverse event: Post surgical infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Post-surgical Pocket Hemorhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 210 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 210 at risk

Adverse event: Psychological effect due to device therapy
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 210 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Unable to capture-LV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 210 at risk

Adverse event: Undersensing-RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ventricular Tacchyarrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Drug abuse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ear reaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 210 at risk

Adverse event: Swollen neck
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: ICD shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Low LVEF
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: High LV lead impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: High RV lead impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Low pacing output
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk