Study: NCT01816776

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 151 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 151 at risk

Adverse event: SUSTAINED VENTRICULAR TACHY ARRHYTHMIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 151 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 151 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: COMPLICATION OF HEART FAILURE THERAPY
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: COMPLICATION OF CARDIAC SURGERY
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: INAPPROPRIATE ICD SHOCK
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: RIGHT HEART PERFORATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sudden death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 151 at risk

Adverse event: DIABETIC TOE
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: GASTROINTESTINAL BLEED SECONDARY TO WARFARIN
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: IMPENDING POCKET EROSION
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 151 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: STIMULATION LEAD DISLODGEMENT (REMEDE SYSTEM)
Serious: yes
Organ System: General disorders
Notes: The stimulation lead pulled out of the target vessel and required the lead to be replaced in order to deliver therapy
Frequency: 2 affected / 151 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: ALTERED MENTAL STATUS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: CONCOMITANT DEVICE INTERACTION
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: ELECTIVE EXPLANT OF REMEDE SYSTEM
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: EXTRA-RESPIRATORY STIMULATION
Serious: yes
Organ System: General disorders
Notes: Discomfort of feeling delivered therapy in areas remote from the diaphragm
Frequency: 1 affected / 151 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: ICD LEAD FAILURE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: STIMULATION LEAD COMPONENT FAILURE (REMEDE SYSTEM)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: STIMULATION LEAD DISPLACEMENT (REMEDE SYSTEM)
Serious: yes
Organ System: General disorders
Notes: The stimulation lead remained in the target vessel but electrode position did not allow for effective therapy delivery
Frequency: 1 affected / 151 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 151 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: ICD IMPLANT SITE INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: LEG CELLULITIS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 151 at risk

Adverse event: Aortic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: Neurological procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: ELEVATED TRANSAMINASE
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 151 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: BICEP TENDON TEAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: RHABDOMYOLOSIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 151 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: URINARY TRACT STENOSIS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: CRT-D IMPLANT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: DRUG ELUTING STENT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: ICD GENERATOR AND RV LEAD REPLACEMENT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: ICD IMPLANT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: LEFT SUBTALAR JOINT ARTHRODESIS, HARDWARE REMOVAL AND BONE GRAFTING
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: DIAPHRAGMATIC STIMULATION DISCOMFORT
Serious: no
Organ System: General disorders
Notes: Discomfort in the abdominal area due to remede System delivered therapy
Frequency: 38 affected / 151 at risk

Adverse event: EXTRA-RESPIRATORY STIMULATION
Serious: no
Organ System: General disorders
Notes: Discomfort of feeling delivered therapy in areas remote from the diaphragm
Frequency: 14 affected / 151 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 151 at risk