Study: NCT01327976

Adverse event: Neuroregulator malfunction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 162 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 162 at risk

Adverse event: Emesis/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pain, neuroregulator site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 162 at risk

Adverse event: Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Subject not implanted
Frequency: 1 affected / 162 at risk

Adverse event: Generalized ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Intra-operative oozing
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pain, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pain, other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 162 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pain, neuroregulator site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 162 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 90 affected / 162 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 162 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 80 affected / 162 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 162 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 162 at risk

Adverse event: Eructation/belching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 162 at risk

Adverse event: Incision pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 162 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 162 at risk

Adverse event: Wound redness or irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 162 at risk

Adverse event: Cold/flu/respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 70 affected / 162 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 162 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 21 affected / 162 at risk

Adverse event: Out of range lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 162 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 162 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 15 affected / 162 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 162 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 162 at risk

Adverse event: Emesis/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 162 at risk

Adverse event: Reaction to medicines
Serious: no
Organ System: General disorders
Frequency: 10 affected / 162 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 162 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 162 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 77 at risk

Adverse event: Worsening back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pain, neuroregulator site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 77 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 40 affected / 77 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 28 affected / 77 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Incision pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 77 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 77 at risk

Adverse event: Wound redness or irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Cold/flu/respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 77 at risk

Adverse event: Out of range lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 11 affected / 77 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Emesis/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Reaction to medicines
Serious: no
Organ System: General disorders
Frequency: 6 affected / 77 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 77 at risk