Study: NCT02385526

Adverse event: Discomfort [S]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Medical device discomfort [S]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Medical device pain [S] [SI]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Cellulitis [U]
Serious: no
Organ System: Infections and infestations
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis [U]
Serious: no
Organ System: Infections and infestations
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Procedural nausea [U]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Back pain [U]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Muscle tightness [SI]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Muscle twitching [S]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Neck pain [I]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 22 at risk

Adverse event: Pain in extremety [I]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Pain in jaw [U] [S]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Headache [U]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia [S]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Postural tremor [S]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Anxiety [U] [SI]
Serious: no
Organ System: Psychiatric disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Asthma [U]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Cough [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 22 at risk

Adverse event: Oropharyngeal pain [I] [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 22 at risk

Adverse event: Throat tightness [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 22 at risk

Adverse event: Palpatations [S]
Serious: no
Organ System: Cardiac disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Constipation [U]
Serious: no
Organ System: Gastrointestinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Dysphagia [S]
Serious: no
Organ System: Gastrointestinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Chest Pain [S]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue [S]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Implant site hoematoma [I]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Medical device pain [S] [SI]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Non-cardiac chest pain [S]
Serious: no
Organ System: General disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection [U]
Serious: no
Organ System: Infections and infestations
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 20 at risk

Adverse event: Incision site hypoaesthesia [I]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Incision site pain [I]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 3 affected / 20 at risk

Adverse event: Procedural headache [S]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Muscle spasms [S]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia [I]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Pain in jaw [U] [S]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Convulsion [U]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Oropharyngeal pain [I] [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 20 at risk

Adverse event: Sleep apnoea syndrome [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Pruritis [S]
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: Peripheral vascular disease of right superficial femoral artery (Post Implant) unrelated to implant or stimulation.
Frequency: 1 affected / 20 at risk

Adverse event: Cerumen impaction [U]
Serious: no
Organ System: Ear and labyrinth disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Tinnitus [U]
Serious: no
Organ System: Ear and labyrinth disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea [U]
Serious: no
Organ System: Gastrointestinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 3 affected / 20 at risk

Adverse event: Lower respiratory tract infection [U]
Serious: no
Organ System: Infections and infestations
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Staphyloccal infection [I]
Serious: no
Organ System: Infections and infestations
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Incision site haematoma [U]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Post procedural haemorrhage [U]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Procedural headache [S]
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia [U]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Muscle twitching [S]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Convulsion [U]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Migraine [U]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Somnolence [U]
Serious: no
Organ System: Nervous system disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 2 affected / 20 at risk

Adverse event: Anxiety [U] [SI]
Serious: no
Organ System: Psychiatric disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Dysphonia [S]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Sputum increased [SI]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral arterial occlusive disease [U]
Serious: no
Organ System: Vascular disorders
Notes: \[S\] Related to Stimulation \[I\] Related to Implant \[SI\] Related to Stimulation and Implant \[U\] Unrelated to Stimulation or Implant
Frequency: 1 affected / 20 at risk