Study: NCT05252702

Adverse event: Cardiac Arrhythmia - Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 452 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 452 at risk

Adverse event: Cardiac Arrhythmia - Supraventricular Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 452 at risk

Adverse event: Infection, Local at Access Site, or Systemic
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 452 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Accidental Injury/Mechanical Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 452 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 452 at risk

Adverse event: Respiratory Failure/Respiratory Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 452 at risk

Adverse event: Electrolyte Disbalance
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 452 at risk

Adverse event: Urinary Tract Infection/UTI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Chest Pain - Non-Cardiac
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 452 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 452 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 452 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 452 at risk

Adverse event: Covid-19 Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 452 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Malignant Tumor/Malignant Disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 452 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Renal Failure/Insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Peripheral Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Valve Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 452 at risk

Adverse event: Gastrointestinal Bleeding/Hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Cardiac Arrhythmia - Ventricular Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 452 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Pneumothorax/Hemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Reaction/Toxic Effect Due to Contrast Media
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 452 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 452 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Mechanical Device Dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Acute Hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 452 at risk

Adverse event: Anal Nodule
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Av Fistula Malfunction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Calciphylaxis of Penis Fistula
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chest Pain Unspecified
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chronic Right Elbow Olecranon Bursitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Prostatomegaly
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 452 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Generalized Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Head Laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 452 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Knee Arthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Atrial appendage closure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Leg Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Low Ejection Fraction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Pseudophakia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Sacroiliac Join Dysfunction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Suicidal Ideations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Vertebrae Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vertigo
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Threshold Elevation
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 452 at risk

Adverse event: Inadequate Fixation During Implant with LP Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 452 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 452 at risk

Adverse event: Inadequate Fixation During Implant Without LP Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Pericardial Effusion or Rub
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Access Site Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Intermittent Capture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Tricuspid Valve Damage And/or Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pacemaker syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 452 at risk

Adverse event: Intermittent or Loss of I2i Communication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 452 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Inability to Release and Redock the LP
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: False Magnet Mode
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Access site Oozing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Device Dislogdement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 452 at risk

Adverse event: Complete AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 452 at risk

Adverse event: Cardiac Arrhythmia - Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 452 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 452 at risk

Adverse event: Covid-19 Infections
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 452 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 29 affected / 452 at risk

Adverse event: Infection, Local at Access Site, or Systemic
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 452 at risk

Adverse event: Urinary Tract Infection/UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 452 at risk

Adverse event: Chest Pain - Non-Cardiac
Serious: no
Organ System: General disorders
Frequency: 17 affected / 452 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 25 affected / 452 at risk

Adverse event: Accidental Injury/Mechanical Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 452 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 452 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 452 at risk

Adverse event: Cardiac Arrhythmia - Supraventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 452 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 7 affected / 452 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 452 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 452 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 452 at risk

Adverse event: Renal Failure/Insufficiency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 452 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 452 at risk

Adverse event: Cardiac Arrhythmia - Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 452 at risk

Adverse event: Electrolyte Disbalance
Serious: no
Organ System: Investigations
Frequency: 5 affected / 452 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 452 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 452 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 452 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 452 at risk

Adverse event: Valve Disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Access Site Bleeding Event
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 452 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 452 at risk

Adverse event: Gastrointestinal Bleeding/Hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Groin pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Oversensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Pericardial Effusion or Rub
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 452 at risk

Adverse event: Peripheral Artery Disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 452 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 452 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 452 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 452 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Lower Extremity Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 452 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 452 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 452 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Chest Pain - Unspecified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 452 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Elevated D-Dimer
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Skin Lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Thyroid Leves Abnormal
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 452 at risk

Adverse event: Adjustment disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Altered Mental State
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Asteatosis Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Asthmatic Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Barrett's oesophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Bilateral Upper Limb Numbness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Chest Pain Unspecified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chronic Dislocated Right Shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cirrhotic Liver
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Coccyx Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Deterioration of Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Parkinsonism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Autonomic nervous system imbalance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 452 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Fistula discharge
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Frontoparietal Meningioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hallucination
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hepatic lesion
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 452 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 452 at risk

Adverse event: Ingrown Toenail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Left Arm Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Left Hand Numbness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Leg Weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Lung Nodules
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Nodules Right Thyroid Gland
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Numbness/Tingling in Lower
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Ophthalmic herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Oral Ulcers
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 452 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Patent Foramen Ovale
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Polyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Pressure in the Head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pulmonary Nodules
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Qt Prolongation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Rapid Heart Rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Anorectal polyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Right Second Toe Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Seizure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Sublingual Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Thyroglossal cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Tongue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Tympan Perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vein Stenosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Venous Disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Blindness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Threshold Elevation
Serious: no
Organ System: General disorders
Frequency: 22 affected / 452 at risk

Adverse event: Intermitted or Loss of I2i Communication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 452 at risk

Adverse event: Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 452 at risk

Adverse event: Inability to Interrogate or Program due to Programmer or LP Malfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 452 at risk

Adverse event: Phrenic Nerve/Diaphragmatic/Extra-Cardiac Stimulation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Intermittent Capture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Pacemaker syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Failure to Capture/Loss of Capture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Tricuspid Valve Damage and/or Regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Interruption of Desired LP Function due to Electrical Interference, Electromyogenic or Electromagnet
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Undersensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: False Magnet Mode
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 452 at risk

Adverse event: Intermittent or Loss of Sensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Access Site Induration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Access Site Oozing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Vascular dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Inability to Release and Redock the LP
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Non-Healing Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 452 at risk

Adverse event: Inability to Interrogate Device Due to Interference from Swan Ganz Continuous Cardiac Output Monitor
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: LP Found in Rom Mode
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Access Site Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Radial Artery Occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk