Study: NCT02671903

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of heart failure
Frequency: 3 affected / 167 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Decompensated / Congestive Cardiac Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: His Lead displacement
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 167 at risk

Adverse event: ICD shock
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 167 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 167 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute on Chronic Kidney Disease
Frequency: 1 affected / 167 at risk

Adverse event: AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Raised His Lead Threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Subclavian vein thrombosis.
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: VT Episodes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 167 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 167 at risk

Adverse event: Exacerbation of HF
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Fall secondary to dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: HIS lead threshold rise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Ventricular Tachycardia Episodes
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Bilateral swollen and painful legs
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: MRSA positive nose and groin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 167 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Endoscopy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 167 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 167 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Ventricular Ectopy burden
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Injury due to Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 167 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: High atrial lead threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypotension and dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Mixed anaerobes in catheter swab
Serious: no
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Adverse chest findings following x-ray
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Nitrites in Urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Pseudomonas in urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: serous fluid found in old generator box site
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 167 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Ventricular Ectopy burden
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Low QRS Duration
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pain and limited mobility in the arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 160 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: ICD trigger VF arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 160 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Decompensated / Congestive Cardiac Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 160 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 160 at risk

Adverse event: Ulcerated legs
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 160 at risk

Adverse event: His Lead displacement
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 160 at risk

Adverse event: abnormal blood sugar levels
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Accidental morphine overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 160 at risk

Adverse event: Ascites
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 160 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Bilateral leg cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Bilateral numbness of arm when lying either side
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Bloatedness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Blocked urethral catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cardiac symptoms of palpitations and hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 160 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 160 at risk

Adverse event: Common Colds
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Diabetic Left Foot Ulcer
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Dry persistent cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Eczema Skin condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Exacerbation of HF
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 160 at risk

Adverse event: Extreme tiredness and fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Fall secondary to dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Feeling of generally unwell
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Fractured foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 160 at risk

Adverse event: Haematuria secondary to NOAC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: HIS lead threshold rise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Hypergylcaemic Episode
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Idiopathic skin condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Impacted ear wax
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 160 at risk

Adverse event: Increased breathlessness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Intermittent cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Laceration to big toe
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: Left eye vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 160 at risk

Adverse event: Left Kidney Stones
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Mechanical Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: mouth ulcer requiring biopsy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: New diagnosis of diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Non cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: nonblanching petechial rashes on both shins
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Non-sustained VT Episodes
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 160 at risk

Adverse event: Painful bilateral knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: painful lower extremeties
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 160 at risk

Adverse event: Polyps in colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Progressive weight loss
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Raised His Lead Threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Received external electrical shock at work (works as an electrician)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: recurrence of atrial arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Recurrence of atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Shortness of breath, Productive cough and wheeze due to lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: skin cancer growth L) hand
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Sprained wrist due to fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Suspected lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Sustained VT treated with ATP
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 160 at risk

Adverse event: swollen bilateral legs (knee to ankle)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Swollen feet
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Swollen left arm secondary to blood clot
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Thyroid Deficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 160 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 160 at risk

Adverse event: Ventricular Tachycardia Episodes
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 160 at risk

Adverse event: Viral Illness of unknown origin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Weight loss and dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Worsening chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Worsening renal function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: worsening shortness of breath and activity tolerance
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Shortness of breath secondary to bilateral pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Acute pulmonary oedema and Aortic valve stenosis with insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 157 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of heart failure
Frequency: 1 affected / 157 at risk

Adverse event: Decompensated / Congestive Cardiac Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 157 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: ICD shock
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 157 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 157 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 157 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 157 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 157 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 157 at risk

Adverse event: Common Colds
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 157 at risk

Adverse event: Exacerbation of HF
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 157 at risk

Adverse event: Extreme tiredness and fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 157 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 157 at risk

Adverse event: Hypergylcaemic Episode
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 157 at risk

Adverse event: Increased breathlessness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 157 at risk

Adverse event: Mechanical Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: New diagnosis of diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 157 at risk

Adverse event: Non-sustained VT Episodes
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 157 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 157 at risk

Adverse event: Polyps in colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 157 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 157 at risk

Adverse event: Ventricular Tachycardia Episodes
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Anterior L1 Compression Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Barrett's oesophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Bilateral swollen and painful legs
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Broken rib
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Cataracts operation on left eye
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 157 at risk

Adverse event: Coronary Sinus lead displaced
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 157 at risk

Adverse event: decreased activity tolerance and increased paroxysmal nocturnal dyspnea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Degenerated rotator cuff and tendinopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 157 at risk

Adverse event: Dislocated R shoulder due to mechanical fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Excessive intestinal gas -belching or flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Fainting spells
Serious: no
Organ System: General disorders
Frequency: 2 affected / 157 at risk

Adverse event: Fall. Walking sticks slipped off.
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 157 at risk

Adverse event: Fracture in left elbow due to a fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Heavily trabeculated bladder with debris in urine noted during flexible cystoscopy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 157 at risk

Adverse event: Increased urinary frequency secondary to enlarged prostate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: insertion of indwelling catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Intermittent high impedance on His Lead with increase in His pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Late His Lead threshold rise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Left leg cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Left lower leg blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: left ventricular thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Lesion in caecum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Marked deterioration of kidney function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Mild Infective Exacerbation of Bronchiectasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: MRSA positive nose and groin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Non-tender pain free lump increasing in size
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Productive cough
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Recurrent Falls secondary to hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Progressive worsening of breathlessness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Reduced mobility
Serious: no
Organ System: General disorders
Frequency: 1 affected / 157 at risk

Adverse event: Right leg cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Shoulder joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Slight palpitations, Chest discomfort.
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: ST elevation on ECG post MVO2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Swollen right leg ?secondary to blood clot
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Tingling sensation in both feet
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 157 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 157 at risk

Adverse event: worsening shortness of breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 157 at risk