Study: NCT02006069

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Atrial or Ventricular Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 271 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 271 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Valve Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Gastrointestinal Disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain at Pulse Generator Site
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 271 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Pain at Pulse Generator Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Abnormal Lead Pacing Impedance <= 200 OHMS or >=2000 OHMS
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Infection
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Lead Dislodgement or Migration
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 271 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 271 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Urinary Tract Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Larynx Perforation After Tee
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pseudo-Nodular Lung Consolidation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Respiratory Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 271 at risk

Adverse event: Peripheral Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Atrial or Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 271 at risk

Adverse event: Exacerbation of Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain at Pulse Generator Site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Worsening of General Patient's Condition
Serious: no
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 271 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 271 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Elevated Pacing Thresholds/Loss of Capture
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 271 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: no
Organ System: Product Issues
Frequency: 13 affected / 271 at risk

Adverse event: Lead Dislodgement or Migration
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 271 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 271 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Palpitations
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 271 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 271 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Kidney Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 271 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Anticoagulant Overdose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Hemopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Atrial or Ventricular Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 555 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 555 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 555 at risk

Adverse event: Cardiorespiratory Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 555 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 555 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 53 affected / 555 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Mitral Valve Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 555 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 555 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 555 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Valve Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 555 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 555 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 555 at risk

Adverse event: Hyperthyroidism Caused by Amiodarone
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 555 at risk

Adverse event: Cataract
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 555 at risk

Adverse event: Abdominal Affliction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Downhill Varicose and Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 555 at risk

Adverse event: Gastrointestinal Disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 555 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 555 at risk

Adverse event: Pancreatic Cystic Lesion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 555 at risk

Adverse event: Nausea, Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 555 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 555 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 555 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 555 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 555 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 555 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Mild Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 555 at risk

Adverse event: Pocket Swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Traumatic Subdural Hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 555 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 555 at risk

Adverse event: Electrolyte Disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 555 at risk

Adverse event: Fluid Accumulation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 555 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 555 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 555 at risk

Adverse event: Myosclerosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 555 at risk

Adverse event: Benign Tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 555 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 555 at risk

Adverse event: Ureteral neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 555 at risk

Adverse event: Cerebellar syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Elevated Pacing Thresholds/Loss of Capture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Lead Dislodgement or Migration
Serious: yes
Organ System: Product Issues
Frequency: 36 affected / 555 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 555 at risk

Adverse event: Pulse Generator Migration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 555 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Dementia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 555 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 555 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 555 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 555 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 555 at risk

Adverse event: Respiratory Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Limb Gangrene
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 555 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 555 at risk

Adverse event: Nose Resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 555 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 555 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 555 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Lower Extremity Claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Peripheral Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 555 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 555 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 555 at risk

Adverse event: Atrial or Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 555 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Exacerbation of Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 555 at risk

Adverse event: Heart transplant
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 555 at risk

Adverse event: Chest pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Mild Diverticulosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 555 at risk

Adverse event: Pain at Pulse Generator Site
Serious: no
Organ System: General disorders
Frequency: 2 affected / 555 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 555 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 555 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 555 at risk

Adverse event: Bodily Rejection Phenomena
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 555 at risk

Adverse event: Elevated Pacing Thresholds/Loss of Capture
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 555 at risk

Adverse event: Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
Serious: no
Organ System: Product Issues
Frequency: 26 affected / 555 at risk

Adverse event: Lead Dislodgement or Migration
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 555 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 555 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 555 at risk

Adverse event: Respiratory Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 555 at risk

Adverse event: Elective Replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 555 at risk

Adverse event: Bleeding/Hematoma/Seroma
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 555 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 555 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 555 at risk