Study: NCT00567541

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 1 affected / 7 at risk

Adverse event: bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-device related
Frequency: 1 affected / 7 at risk

Adverse event: Implant site pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: device related
Frequency: 1 affected / 7 at risk

Adverse event: Increased pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: device related
Frequency: 1 affected / 7 at risk

Adverse event: Pain other than at implant site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: device related
Frequency: 1 affected / 7 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: device related
Frequency: 2 affected / 7 at risk

Adverse event: Edema/Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: device related
Frequency: 4 affected / 7 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 1 affected / 7 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 4 affected / 7 at risk

Adverse event: Nausea, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-device related
Frequency: 1 affected / 7 at risk

Adverse event: Flu, shingles
Serious: no
Organ System: Infections and infestations
Notes: non-device related
Frequency: 1 affected / 7 at risk

Adverse event: general complaints
Serious: no
Organ System: General disorders
Notes: non-device related
Frequency: 3 affected / 7 at risk

Adverse event: Spasticity, hang grip issues
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 2 affected / 7 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 4 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: non-device related
Frequency: 1 affected / 9 at risk

Adverse event: bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-device related
Frequency: 1 affected / 9 at risk

Adverse event: Implant site pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: device related
Frequency: 1 affected / 9 at risk

Adverse event: Increased pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: device related
Frequency: 1 affected / 9 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: device related
Frequency: 1 affected / 9 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: device related
Frequency: 4 affected / 9 at risk

Adverse event: Collateral Muscle Stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: device related
Frequency: 1 affected / 9 at risk

Adverse event: Edema/Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: device related
Frequency: 2 affected / 9 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 3 affected / 9 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 1 affected / 9 at risk

Adverse event: Nausea, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-device related
Frequency: 3 affected / 9 at risk

Adverse event: Flu, shingles
Serious: no
Organ System: Infections and infestations
Notes: non-device related
Frequency: 1 affected / 9 at risk

Adverse event: general complaints
Serious: no
Organ System: General disorders
Notes: non-device related
Frequency: 6 affected / 9 at risk

Adverse event: Spasticity, hang grip issues
Serious: no
Organ System: Nervous system disorders
Notes: non-device related
Frequency: 3 affected / 9 at risk