Study: NCT02384421

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: serious, anticipated, device related
Frequency: 1 affected / 22 at risk

Adverse event: Lead/Connection Break
Serious: yes
Organ System: Product Issues
Notes: serious, anticipated, device related
Frequency: 1 affected / 22 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: serious, unanticipated, non-device related
Frequency: 1 affected / 22 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: serious, unanticipated, non-device related
Frequency: 1 affected / 22 at risk

Adverse event: Device failure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 22 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Tenderness
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 22 at risk

Adverse event: Sensing Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 22 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 22 at risk

Adverse event: Gait Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Speech
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cognitive Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Balance
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Muscle Contractions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 22 at risk

Adverse event: Cognitive Problems
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: Speech Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 22 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 22 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Slowness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 22 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 22 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain/Soreness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Urinary Issues
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Weight changes
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Sleep Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 22 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Difficult Swallowing/Salivation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 22 at risk

Adverse event: Dreaming
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cough/Throat
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Restless Leg
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Delerium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vision problems
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 22 at risk

Adverse event: Kidney Issues
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Blood pressure measurement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Body temperature
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk