Study: NCT02066467

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 838 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 838 at risk

Adverse event: Adverse reaction - Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 838 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Arterial/venous thrombolytic event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 838 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 838 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 838 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 838 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 838 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 838 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 838 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 838 at risk

Adverse event: Coronary venous dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 838 at risk

Adverse event: Device Deficiency
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Extracardiac stimulation- LV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - No reported signs - RA
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 838 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Dislodgment - Unable to capture - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Unable to capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 838 at risk

Adverse event: Elevated threshold - LV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 838 at risk

Adverse event: Erosion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Extracardiac stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Extracardiac stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 838 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 838 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 838 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 838 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 838 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 838 at risk

Adverse event: Hematoma - Pocket (<= 30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 838 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 838 at risk

Adverse event: Impedance > 2000 ohms - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate tachy therapy - Noise
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 838 at risk

Adverse event: Inappropriate tachy therapy- NSR
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: yes
Organ System: Product Issues
Frequency: 10 affected / 838 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 838 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 838 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 838 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 838 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 838 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Myocardial perforation post-implant - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Myocardial perforation post-implant - RV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Myocardial perforation without tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 838 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Other - Lead
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 838 at risk

Adverse event: Other - Lead - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 838 at risk

Adverse event: Other - PG system
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Other - PG system - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 838 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 838 at risk

Adverse event: Other- Patient condition - Non- cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 838 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Oversensing - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Pacemaker-mediated tachycardia (PMT)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 838 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 838 at risk

Adverse event: Pleural effusion - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 838 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 838 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 838 at risk

Adverse event: Post-surgical wound discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 838 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 838 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 838 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 838 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Unable to capture - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 838 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 838 at risk

Adverse event: Weight gain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 3 affected / 838 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 2 affected / 838 at risk

Adverse event: Adverse reaction - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 838 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 838 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 838 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Coronary venous dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 838 at risk

Adverse event: Device Deficiency
Serious: no
Organ System: Product Issues
Frequency: 33 affected / 838 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Dislodgment - Elevated threshold -RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Unable to capture - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dislodgment - Undersensing - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 838 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 838 at risk

Adverse event: Elevated threshold - LV
Serious: no
Organ System: Product Issues
Frequency: 13 affected / 838 at risk

Adverse event: Elevated threshold - RA
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Elevated threshold - RV
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 838 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 47 affected / 838 at risk

Adverse event: Extracardiac stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 838 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 838 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 838 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 838 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 838 at risk

Adverse event: Hematoma - Pocket (<= 30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 838 at risk

Adverse event: Hematoma - Pocket (> 30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Hematoma - Unrelated to procedure or device
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Hypertension - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Hypotension - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Impedance > 2000 ohms - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Impedance > 2000 ohms - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Impedance > 2000 ohms - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate AV delay
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 838 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 838 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 838 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 838 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 838 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 838 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Other - Lead
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 838 at risk

Adverse event: Other - Lead - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 87 affected / 838 at risk

Adverse event: Other - PG system
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Other - PG system - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 838 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Other- Patient condition - Non- cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 838 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Pacemaker-mediated tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Pericarditis - Unrelated to procedure or device
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 838 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 838 at risk

Adverse event: Pleural effusion - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 838 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 838 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 838 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 838 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 838 at risk

Adverse event: Rate response inappropriate
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 838 at risk

Adverse event: RVAT Communication
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 838 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Unable to capture - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 838 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 838 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 838 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 838 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 838 at risk