Study: NCT02468934

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Nausea/Upset Stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: One event was study-related, and the other was not
Frequency: 2 affected / 24 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Notes: One event was study-related, and the other two were not
Frequency: 3 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Small dehiscence at Total Knee Arthroplasty (TKA) surgical site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Iliotibial Band Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Muscle Pain/Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Three events were study-related, and one was not
Frequency: 2 affected / 24 at risk

Adverse event: Increased Pain (Hip and Leg)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two events were not study-related, and the relationship to the study was unable to be determined for the other event
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Relationship to study unable to be determined
Frequency: 1 affected / 24 at risk

Adverse event: Pain due to Stimulation
Serious: no
Organ System: Product Issues
Notes: Study-related
Frequency: 1 affected / 24 at risk

Adverse event: Shocks at Lead Exit Site
Serious: no
Organ System: Product Issues
Notes: Study-related
Frequency: 2 affected / 24 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Skin irritation or bruising at Lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 7 affected / 24 at risk

Adverse event: Skin irritation/dermatitis from bandages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 3 affected / 24 at risk

Adverse event: Skin irritation from SPRINT Pad
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 4 affected / 24 at risk

Adverse event: Non-specified skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Two events were study-related, and the other one was not
Frequency: 3 affected / 24 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relationship to study unable to be determined
Frequency: 1 affected / 24 at risk

Adverse event: Affected Leg Swelling
Serious: no
Organ System: Vascular disorders
Notes: Study-related
Frequency: 1 affected / 24 at risk

Adverse event: Knee Stiffness/Decreased Range of Motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 24 at risk