Study: NCT00930969

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 175 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 175 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 175 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 175 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 175 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 175 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 175 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 175 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 175 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 175 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 175 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 175 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 175 at risk

Adverse event: Device use issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 175 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 175 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 175 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Clostridial sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Dressler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Gastritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Gout
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Haematuria
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Incision site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hydrocele male infected
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Lower extremity edema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Lymph node abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Obesity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Phimosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Post-traumatic headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Renal mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Stomach mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Thyroglossal cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 175 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: General disorders
Frequency: 6 affected / 175 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 175 at risk