Study: NCT02928055

Adverse event: other medical condition: Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Reported diagnosis of ca, follow up phase
Frequency: 2 affected / 8 at risk

Adverse event: Anxiety(psychosocial)
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject hospitalized 2 days for complaints of chest pain after family disagreement. Reported a brief period of suicidal ideation. Discharge diagnosis- chest pain which appeared to be triggered by psychosocial issues
Frequency: 1 affected / 8 at risk

Adverse event: Skin Irritation at Bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching at bandage site
Frequency: 5 affected / 8 at risk

Adverse event: Skin Irritation under Sprint Pad
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness under sprint pad
Frequency: 1 affected / 8 at risk

Adverse event: Retained Lead Fragment
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Lead fragment retained in muscle after explant
Frequency: 1 affected / 8 at risk

Adverse event: Accidental dislodgment of Lead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: subject accidentally pulled lead out for skin
Frequency: 2 affected / 8 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: fall with fracture
Frequency: 1 affected / 8 at risk

Adverse event: Skin Irritation at electrode site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: redness at electrode site(no infection)
Frequency: 1 affected / 8 at risk

Adverse event: Fall with injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall resulting in avulsion fracture of styloid process
Frequency: 1 affected / 8 at risk

Adverse event: Orthopedic surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Orthopedic Foot surgery
Frequency: 1 affected / 8 at risk

Adverse event: Skin Irritation at Bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching at bandage site
Frequency: 2 affected / 8 at risk

Adverse event: Skin Irritation under Sprint Pad
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness under sprint pad
Frequency: 1 affected / 8 at risk

Adverse event: Retained Lead Fragment
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Lead fragment retained in muscle after explant
Frequency: 1 affected / 8 at risk

Adverse event: Accidental dislodgment of Lead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: subject accidentally pulled lead out for skin
Frequency: 2 affected / 8 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: fall with fracture
Frequency: 2 affected / 8 at risk

Adverse event: Skin Irritation at electrode site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: redness at electrode site(no infection)
Frequency: 2 affected / 8 at risk

Adverse event: Skin Irritation at Bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching at bandage site
Frequency: 4 affected / 7 at risk

Adverse event: Accidental dislodgment of Lead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: subject accidentally pulled lead out for skin
Frequency: 1 affected / 7 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: fall with fracture
Frequency: 1 affected / 7 at risk

Adverse event: Skin Irritation at electrode site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: redness at electrode site(no infection)
Frequency: 2 affected / 7 at risk

Adverse event: Arm fatigue/weakness/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: pain or weakness in shoulder reported after implantation and start of stimulation
Frequency: 2 affected / 7 at risk