Study: NCT01094301

Adverse event: Complaints of Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: One event was not study-related, and the relationship of one was unable to be determined
Frequency: 1 affected / 28 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Acute heart failure exacerbation
Serious: yes
Organ System: Cardiac disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Not study-related
Frequency: 3 affected / 28 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Not study-related
Frequency: 2 affected / 28 at risk

Adverse event: Skin Irritation (redness, mild skin abrasion, or mild grade 1 pressure sore with intact skin)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Eleven were Study-related, and one was unrelated
Frequency: 11 affected / 28 at risk

Adverse event: Painful Stimulation
Serious: no
Organ System: Product Issues
Notes: Six were study-related, and the relationship of one was unable to be determined
Frequency: 4 affected / 28 at risk

Adverse event: Painful Keloid
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 1 affected / 28 at risk

Adverse event: Granuloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 5 affected / 28 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Notes: Study-related
Frequency: 1 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 5 affected / 28 at risk

Adverse event: Tenderness at lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study-related
Frequency: 1 affected / 28 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 4 affected / 28 at risk

Adverse event: Migraines
Serious: no
Organ System: Nervous system disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Atypical sensation (Tingling/Quivering of fingers/hands or "shock-like" episode after lead removal)
Serious: no
Organ System: General disorders
Notes: One was not study-related and the other two were unable to be determined
Frequency: 3 affected / 28 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Subconjunctival hematoma
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Total body aches
Serious: no
Organ System: General disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Ipsilateral spasms of upper arm and shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Report of redness on hand
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Elbow stiffness and appearance of fluid
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Benign tumor index finger
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study-related
Frequency: 1 affected / 28 at risk

Adverse event: Release of achilles tendon
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study-related
Frequency: 1 affected / 28 at risk