Study: NCT03286543

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not study-related
Frequency: 1 affected / 18 at risk

Adverse event: Sepsis due to Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Notes: Not study-related
Frequency: 1 affected / 18 at risk

Adverse event: Skin irritation at bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 2 affected / 18 at risk

Adverse event: Skin irritation or bruising at pad and/or Lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 4 affected / 18 at risk

Adverse event: New hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One event was study-related, and the other was not
Frequency: 1 affected / 18 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Worsening knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Muscle spasming
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Sciatica and Piriformis Syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Thumb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Soreness after Lead placement
Serious: no
Organ System: Product Issues
Notes: Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Shocking at Lead site
Serious: no
Organ System: Product Issues
Notes: Study-Related
Frequency: 1 affected / 18 at risk

Adverse event: Restless Leg Syndrome flare up
Serious: no
Organ System: Nervous system disorders
Notes: Unable to determine relationship to study
Frequency: 1 affected / 18 at risk

Adverse event: Illness
Serious: no
Organ System: General disorders
Notes: Not Study-Related
Frequency: 2 affected / 18 at risk

Adverse event: Acute Myopericarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Not study-related
Frequency: 1 affected / 23 at risk

Adverse event: Pain at TKA Surgical Site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 23 at risk

Adverse event: Adverse Drug Reaction During TKA
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not study-related
Frequency: 1 affected / 23 at risk

Adverse event: Acute Pancreatitis and Gall Stones
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not study-related
Frequency: 1 affected / 23 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Discharge from TKA surgical incision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Burning sensation and swelling of knee
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: New hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One event was study-related, and the other was not
Frequency: 1 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Pain at TKA surgical site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Joint ankylosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Worsening cataract
Serious: no
Organ System: Eye disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not Study-Related
Frequency: 1 affected / 23 at risk

Adverse event: Illness
Serious: no
Organ System: General disorders
Notes: Not Study-Related
Frequency: 3 affected / 23 at risk