Study: NCT00478933

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Abdominal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1145 at risk

Adverse event: aneamia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1145 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1145 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1145 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 1145 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Cerebellar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1145 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1145 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: cororary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1145 at risk

Adverse event: deep venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1145 at risk

Adverse event: Device electrical impedance issue
Serious: yes
Organ System: Product Issues
Frequency: 9 affected / 1145 at risk

Adverse event: Device extrusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1145 at risk

Adverse event: Device issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1145 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1145 at risk

Adverse event: Device lead issue
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1145 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 1145 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1145 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1145 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1145 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: gastrointestinal uler haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1145 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Hypertensive nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1145 at risk

Adverse event: Ill-defined disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1145 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1145 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1145 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Inflammatory marker increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1145 at risk

Adverse event: invertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: ischaemic cardiomayopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 20 affected / 1145 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Medical device site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Medical device site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: opthalmic herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 1145 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Paroxysmal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Peripheral artery stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1145 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1145 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Silent myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1145 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Therapy non-responder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Traumatic haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 1145 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1145 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1145 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1145 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Acute haemorrhagic ulcerative colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Alcohol poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1145 at risk

Adverse event: Cardiac death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1145 at risk

Adverse event: Cardiac failure acute
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Device extrusion
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1145 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1145 at risk

Adverse event: Hypertensive emergency
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1145 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Medical device site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1145 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1145 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1145 at risk

Adverse event: Wound secretion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1145 at risk