Study: NCT00187278

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 908 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: device pocket revision, lead dysfunction.
Frequency: 3 affected / 908 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 908 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Thromboemboli
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 908 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 908 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 908 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 908 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 908 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 908 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 908 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 908 at risk

Adverse event: Exacerbation of heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 132 affected / 908 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 908 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 908 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 908 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Rise in threshold and exit block
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 908 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 908 at risk

Adverse event: Valve damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 908 at risk

Adverse event: Lowry Wood Syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 908 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 10 affected / 908 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 908 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 908 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 908 at risk

Adverse event: Galucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 908 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 908 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 908 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 908 at risk

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 908 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 908 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 908 at risk

Adverse event: Hospitalization for non-cardiac diseases
Serious: yes
Organ System: General disorders
Frequency: 74 affected / 908 at risk

Adverse event: Influenza
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 908 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 47 affected / 908 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 908 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 908 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 908 at risk

Adverse event: Worsening of General Patient's Condition
Serious: yes
Organ System: General disorders
Frequency: 39 affected / 908 at risk

Adverse event: Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 908 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 58 affected / 908 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 908 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 908 at risk

Adverse event: Abdominal adhesions post surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 908 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 908 at risk

Adverse event: Air emboli
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 908 at risk

Adverse event: Amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 908 at risk

Adverse event: Cardiac or venous perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 908 at risk

Adverse event: Cardiac/coronary sinus dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 908 at risk

Adverse event: Coronary sinus or cardiac vein thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 908 at risk

Adverse event: Excessive bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 908 at risk

Adverse event: Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 908 at risk

Adverse event: Hematoma/seroma formation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 908 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Medication error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 908 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 908 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 908 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 908 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 908 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 908 at risk

Adverse event: Adenomatous polyps
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 908 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 24 affected / 908 at risk

Adverse event: Local tissue reaction; formation of fibrotic tissue; cyst formation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 908 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 33 affected / 908 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 908 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 908 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 908 at risk

Adverse event: Sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Inappropriate shocks
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 908 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 908 at risk

Adverse event: Lead migration, dislodgment or poor lead placement
Serious: yes
Organ System: Product Issues
Frequency: 31 affected / 908 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 908 at risk

Adverse event: Mechanical malfunction of the pacing lead
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 908 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 908 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 908 at risk

Adverse event: Pacing Lead Impedance Out of Range
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 908 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 908 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 908 at risk

Adverse event: Macrohematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nephrocalcinosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 908 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 908 at risk

Adverse event: Urinary Track Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 908 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 908 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 908 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 908 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 908 at risk

Adverse event: Respiratory Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 908 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Coronary artery bypass surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Endoscopic retrograde cholangiopancreatography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Iron Infusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 27 affected / 908 at risk

Adverse event: Planned Lead Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Planned Pulse Generator Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 191 affected / 908 at risk

Adverse event: Pulse Generator Pocket Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 77 affected / 908 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 908 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 908 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 908 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Fluid accumulation
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 908 at risk

Adverse event: Lim Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 908 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 908 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 908 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 908 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 908 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Thromboemboli
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 908 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 96 affected / 908 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 908 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 908 at risk

Adverse event: Exacerbation of heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 908 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 908 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 908 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 908 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 908 at risk

Adverse event: Rise in threshold and exit block
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 908 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 908 at risk

Adverse event: Valve damage
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 908 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 908 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 908 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 908 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 908 at risk

Adverse event: Toxic nodular goitre
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 908 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 908 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 908 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 908 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 908 at risk

Adverse event: Hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 908 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 908 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 19 affected / 908 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 908 at risk

Adverse event: Genital prolapse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hospitalization for non-cardiac diseases
Serious: no
Organ System: General disorders
Frequency: 24 affected / 908 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 2 affected / 908 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 908 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: General disorders
Frequency: 3 affected / 908 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 908 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 12 affected / 908 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 908 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 908 at risk

Adverse event: Worsening of General Patient's Condition
Serious: no
Organ System: General disorders
Frequency: 51 affected / 908 at risk

Adverse event: Dysfibrinogenemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 908 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 908 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 908 at risk

Adverse event: Air emboli
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Amputation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Cardiac or venous perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Erosion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Excessive bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 908 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 908 at risk

Adverse event: Hematoma/seroma formation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 908 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 908 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 908 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 908 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 908 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 908 at risk

Adverse event: Bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 908 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 908 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 908 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 908 at risk

Adverse event: Local tissue reaction; formation of fibrotic tissue; cyst formation
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 908 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 908 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 908 at risk

Adverse event: Parethesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 908 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Inappropriate mode switch
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 908 at risk

Adverse event: Inappropriate shocks
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 908 at risk

Adverse event: Lead migration, dislodgment or poor lead placement
Serious: no
Organ System: Product Issues
Frequency: 26 affected / 908 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 908 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 908 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 908 at risk

Adverse event: Pacing Lead Impedance Out of Range
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 908 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 908 at risk

Adverse event: Elevated uric acid
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 908 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Prostatism
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 908 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 908 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 908 at risk

Adverse event: Urinary Track Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 908 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 908 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 908 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 908 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 908 at risk

Adverse event: Respiratory Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 908 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Mastitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Rosacea on Face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 908 at risk

Adverse event: Colposcopy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Percutaneous coronary intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 908 at risk

Adverse event: Planned Lead Revision
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 908 at risk

Adverse event: Planned Pulse Generator Replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 908 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 52 affected / 908 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 908 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Fluid accumulation
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 908 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 908 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 908 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 908 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 902 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: device pocket revision, lead dysfunction.
Frequency: 2 affected / 902 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Thromboemboli
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 902 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 902 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 902 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 902 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 902 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 60 affected / 902 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 902 at risk

Adverse event: Exacerbation of heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 103 affected / 902 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 902 at risk

Adverse event: Hypertrophic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 902 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 902 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 902 at risk

Adverse event: Rise in threshold and exit block
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 902 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 902 at risk

Adverse event: Valve damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 902 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 902 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 902 at risk

Adverse event: Glycemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 902 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 902 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 902 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 902 at risk

Adverse event: Galucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 902 at risk

Adverse event: Macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 902 at risk

Adverse event: Gastrointestinal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 902 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 902 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 902 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 902 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 902 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 902 at risk

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 902 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 902 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 902 at risk

Adverse event: Hospitalization for non-cardiac diseases
Serious: yes
Organ System: General disorders
Frequency: 87 affected / 902 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Influenza
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Lyme disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 55 affected / 902 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 902 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 902 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 902 at risk

Adverse event: Worsening of General Patient's Condition
Serious: yes
Organ System: General disorders
Frequency: 59 affected / 902 at risk

Adverse event: Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 902 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 902 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 902 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 87 affected / 902 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 902 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 902 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 35 affected / 902 at risk

Adverse event: Air emboli
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 902 at risk

Adverse event: Amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Cardiac or venous perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 902 at risk

Adverse event: Cardiac/coronary sinus dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 902 at risk

Adverse event: Coronary sinus or cardiac vein thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 902 at risk

Adverse event: Erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Excessive bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 902 at risk

Adverse event: Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 902 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 902 at risk

Adverse event: Hematoma/seroma formation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 902 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 902 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 902 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 902 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 902 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 32 affected / 902 at risk

Adverse event: Local tissue reaction; formation of fibrotic tissue; cyst formation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 902 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 35 affected / 902 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 902 at risk

Adverse event: Dimentia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 902 at risk

Adverse event: Orthostatic intolerance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 902 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 902 at risk

Adverse event: Inappropriate mode switch
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Lead migration, dislodgment or poor lead placement
Serious: yes
Organ System: Product Issues
Frequency: 36 affected / 902 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 902 at risk

Adverse event: Mechanical malfunction of the pacing lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 902 at risk

Adverse event: Pacing Lead Impedance Out of Range
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 902 at risk

Adverse event: Pulse Generator Reset
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cardiac or venous perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 902 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 902 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 902 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Urinary Track Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 902 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 902 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 902 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 902 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 902 at risk

Adverse event: Respiratory Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 902 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Colposcopy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 902 at risk

Adverse event: Coronary artery bypass surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 902 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 19 affected / 902 at risk

Adverse event: Planned Pulse Generator Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 306 affected / 902 at risk

Adverse event: Pulse Generator Pocket Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 902 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 80 affected / 902 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 902 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 902 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 902 at risk

Adverse event: Fluid accumulation
Serious: yes
Organ System: Vascular disorders
Frequency: 35 affected / 902 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 902 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 902 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 902 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 902 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 902 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 902 at risk

Adverse event: Bicytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 902 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Thromboemboli
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 902 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 107 affected / 902 at risk

Adverse event: Arteritis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 902 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 47 affected / 902 at risk

Adverse event: Exacerbation of heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 902 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 902 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 902 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 902 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 902 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 902 at risk

Adverse event: Percutaneous coronary intervention
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 902 at risk

Adverse event: Rise in threshold and exit block
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 902 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 902 at risk

Adverse event: Valve damage
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 902 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 902 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 902 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 902 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 902 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 902 at risk

Adverse event: Galucoma
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 902 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 902 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 902 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 902 at risk

Adverse event: Hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 902 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 902 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 902 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: General disorders
Frequency: 3 affected / 902 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 902 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 902 at risk

Adverse event: Hospitalization for non-cardiac diseases
Serious: no
Organ System: General disorders
Frequency: 18 affected / 902 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 53 affected / 902 at risk

Adverse event: Prolapse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Short Loss of Consciousness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 902 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 12 affected / 902 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 902 at risk

Adverse event: Worsening of General Patient's Condition
Serious: no
Organ System: General disorders
Frequency: 50 affected / 902 at risk

Adverse event: Gallbladder disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 902 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 902 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 902 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 902 at risk

Adverse event: Acute hemorrhage/bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 902 at risk

Adverse event: Air emboli
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 902 at risk

Adverse event: Asystole during implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Coronary Sinus Cannulation Failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 902 at risk

Adverse event: Cardiac or venous perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 902 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Cardiac/coronary sinus dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Coronary sinus or cardiac vein thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 77 affected / 902 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 902 at risk

Adverse event: Hematoma/seroma formation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 902 at risk

Adverse event: Inverted connection of RV and LV Leads
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 902 at risk

Adverse event: Steal syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 902 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 902 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 902 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 902 at risk

Adverse event: Local tissue reaction; formation of fibrotic tissue; cyst formation
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 902 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 902 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 902 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 902 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 902 at risk

Adverse event: Decreased CRT pacing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Inability to defibrillate
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Inappropriate mode switch
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Lead migration, dislodgment or poor lead placement
Serious: no
Organ System: Product Issues
Frequency: 42 affected / 902 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 902 at risk

Adverse event: Mechanical malfunction of the pacing lead
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 902 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 902 at risk

Adverse event: Pacing Lead Impedance Out of Range
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 902 at risk

Adverse event: Pulse Generator Reset
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 902 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 902 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 902 at risk

Adverse event: Kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 902 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 902 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 902 at risk

Adverse event: Urinary Track Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 902 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 902 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 902 at risk

Adverse event: Nocturnal desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 902 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 902 at risk

Adverse event: Respiratory Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 902 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 902 at risk

Adverse event: Colposcopy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 902 at risk

Adverse event: Medication Titration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 902 at risk

Adverse event: Percutaneous coronary intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 902 at risk

Adverse event: Planned Pulse Generator Replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 15 affected / 902 at risk

Adverse event: Pulse Generator Pocket Revision
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 902 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 52 affected / 902 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 902 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 902 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 902 at risk

Adverse event: Fluid accumulation
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 902 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 902 at risk

Adverse event: Lim Ischemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 902 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 902 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 902 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 902 at risk