Study: NCT02577354

Adverse event: Implant site infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 102 at risk

Adverse event: Intra-operative airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Implant site pocket pain/discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 102 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Notes: Discomfort associated with stimulation, often related to the titration of therapy and typically resolved with reprogramming.
Frequency: 7 affected / 102 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 102 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 102 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Implant site pocket pain/discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 102 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Malignant melanoma stage IV
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Implant site pocket pain/discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 99 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Notes: Discomfort associated with stimulation, often related to the titration of therapy and typically resolved with reprogramming.
Frequency: 5 affected / 99 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Implant site pocket pain/discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 99 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Notes: Discomfort associated with stimulation, often related to the titration of therapy and typically resolved with reprogramming.
Frequency: 12 affected / 99 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 99 at risk