Study: NCT03179202

Adverse event: Shoulder procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Heart procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Liver/Lymph node metastases
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: SCS trial and permanent implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Irritation at pad and/or Lead exit sites
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 16 affected / 99 at risk

Adverse event: Irritation or bruising at bandage site or connector cradles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 19 affected / 99 at risk

Adverse event: Mild swelling following Lead removal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unable to determine relationship to study
Frequency: 1 affected / 99 at risk

Adverse event: Itching at pad and/or Lead exit sites
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 11 affected / 99 at risk

Adverse event: Itching at bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 13 affected / 99 at risk

Adverse event: Discoloration/bruising at Lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 2 affected / 99 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Discharge or bleeding from electrode/insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 3 affected / 99 at risk

Adverse event: Granuloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 2 affected / 99 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-Related
Frequency: 2 affected / 99 at risk

Adverse event: New leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Pain from Lead Placement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 3 affected / 99 at risk

Adverse event: Pain/discomfort at lead site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 5 affected / 99 at risk

Adverse event: Pain from stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 2 affected / 99 at risk

Adverse event: Uncomfortable stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Six events were study-related and two event relationships were unable to be determined.
Frequency: 8 affected / 99 at risk

Adverse event: Worsening low back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One event was study-related, and three events were not related to the study.
Frequency: 4 affected / 99 at risk

Adverse event: Exacerbation of low back pain from medial branch block
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Shoulder and/or hip conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 3 affected / 99 at risk

Adverse event: Thoracic pain/hematoma from fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Pain (distal or unrelated to device location)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Five events were not related to the study and one event relationship was unable to be determined.
Frequency: 6 affected / 99 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Vasovagal dizziness following lead placement
Serious: no
Organ System: Cardiac disorders
Notes: One event was study-related, and the other relationship was unable to be determined
Frequency: 2 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Bacterial pneumonia
Serious: no
Organ System: General disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Strep throat
Serious: no
Organ System: General disorders
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Notes: Not Study-Related
Frequency: 2 affected / 99 at risk

Adverse event: Sinuplasty
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Toenail removal
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Shoulder procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk

Adverse event: Hip procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Study-Related
Frequency: 1 affected / 99 at risk