Study: NCT00271154

Adverse event: Cardiac failure acute
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 191 at risk

Adverse event: Medical device change
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 191 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 191 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 191 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 191 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 191 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 191 at risk

Adverse event: Device use issue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 191 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: RV lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 191 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 191 at risk

Adverse event: Inappropriate device irritation of tissue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 191 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 191 at risk

Adverse event: RA lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Device signal detection issue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Contusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac procedure complication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Constipation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Device related infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Goitre
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Hemianopsia homonymous
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Incision site complication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Joint swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Low cardiac output syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Renal cancer metastatic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Spondylolysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Throat lesion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Viral infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac failure chronic
Serious: no
Organ System: General disorders
Frequency: 24 affected / 119 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 119 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 119 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 119 at risk

Adverse event: Inappropriate device irritation of tissue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 119 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 10 affected / 119 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 119 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: General disorders
Frequency: 56 affected / 419 at risk

Adverse event: Medical device change
Serious: yes
Organ System: General disorders
Frequency: 45 affected / 419 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 419 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 419 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 419 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 419 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 419 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 419 at risk

Adverse event: Device use issue
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 419 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 419 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 419 at risk

Adverse event: RV lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 419 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 419 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Inappropriate device irritation of tissue
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 419 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 419 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 419 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 419 at risk

Adverse event: RA lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 419 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 419 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 419 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 419 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 419 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Asthma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Device signal detection issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Contusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Prostate examination abnormal
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 419 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Oversensing
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anxiety disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Aortic thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Biopsy liver
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardiac ablation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardio-renal syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardiomyopathy alcoholic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Colostomy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Contrast media reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Decreased RV Sensing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Device electrical finding
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Dislodgement of LV lead
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Diverticulitis oesophageal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hairy cell leukaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Haematoma evacuation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypervolemic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Implant site erosion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Implant site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Implant site irritation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Iodine allergy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Lung consolidation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Melaena
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Mitral valve repair
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Nodal arrhythmia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Orthostatic intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Palpitations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pituitary tumor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Skin irritation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Tonsillar disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Tooth disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Urinary bladder adenoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Valvuloplasty cardiac
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Venous stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Ventricular assist device insertion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vertigo CNS origin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vestibular neuronitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vocal cord polyp
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Vocal cord thickening
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Cardiac failure chronic
Serious: no
Organ System: General disorders
Frequency: 31 affected / 491 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 47 affected / 491 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 25 affected / 491 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 491 at risk

Adverse event: Inappropriate device irritation of tissue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 491 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 16 affected / 491 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 491 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Medical device change
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Asthma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Contusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Leukothrombopenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac failure chronic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Inappropriate device irritation of tissue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk