Study: NCT00547729

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 71 at risk

Adverse event: False Positive Blood Cultures
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Thromboemboli
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 71 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Atrial Fibrillation with RVR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 71 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 71 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 71 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 71 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 71 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 71 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pleuritic chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Body Tingling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 71 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 71 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 71 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 71 at risk

Adverse event: Iritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 71 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 71 at risk

Adverse event: Air emboli
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac or venous perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 71 at risk

Adverse event: Erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 71 at risk

Adverse event: Hematoma/seroma formation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 71 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Right and Left Atrium Thrombus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 71 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 71 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 71 at risk

Adverse event: Fidelis Medtronic RV lead impedance out of range
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Inappropriate ICD Shocks
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Lead Failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Sensor Drift
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 71 at risk

Adverse event: Prostatism
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 71 at risk

Adverse event: Ureteral Stricture and Dilatation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Urinary Retension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Atrial Pressure Sensor Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: AV Fistula Creation for Dialysis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Balloon Cystoscopy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Chemotherapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: LVAD Repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Percutaneous Mitral Repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned CRT implant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 71 at risk

Adverse event: Planned CRT replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned Device Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned ICD Implant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned LVAD Implant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned Pacemaker Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned Pulse Generator Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned Upgrade to CRT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 71 at risk

Adverse event: Carotid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 71 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 71 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 71 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Abdominal Bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Episode of Vagueness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 3 affected / 71 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 71 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 71 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 71 at risk

Adverse event: Discomfort at device location
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Hematoma/seroma formation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 71 at risk

Adverse event: Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Sedation complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Wound Tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Abnormal lab results
Serious: no
Organ System: Investigations
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Femoral Nerve Irritation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypotension
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Vasovagal Episode
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Bradycardia due to ICD RV lead dislodgement
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 71 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 71 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Cholecystectomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Elective Cataract Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Lightheadedness during Valsalva
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Planned Knee Replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 71 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 71 at risk

Adverse event: Hypotention
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk