Study: NCT02428595

Adverse event: Vaginal Mucosal Wall Injury
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Abrasion, bleeding, erythema, petechia, ecchymosis, hyperemia, or erosion of vaginal tissue apparent during pelvic examination.
Frequency: 40 affected / 137 at risk

Adverse event: Lower Urinary Tract Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: New or increased urinary incontinence or voiding difficulty or urinary frequency, urinary tract infections, or dysuria.
Frequency: 20 affected / 137 at risk

Adverse event: Vaginal/Pelvic Discomfort/Irritation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vaginal/Pelvic discomfort, pain, irritation, discharge, odor, burning sensation, or itching.
Frequency: 18 affected / 137 at risk

Adverse event: Vaginal Infections
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Yeast infection of the vagina or unspecified vaginitis. Does not include systemic yeast infections or infections of other areas that do not affect the vagina.
Frequency: 2 affected / 137 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Leg pain.
Frequency: 1 affected / 137 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related. Patient hospitalized for chest pain, underwent heart catheterization.
Frequency: 1 affected / 73 at risk

Adverse event: Suicidal ideations
Serious: yes
Organ System: Psychiatric disorders
Notes: Not device related.
Frequency: 1 affected / 73 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Not device related.
Frequency: 2 affected / 73 at risk

Adverse event: Acute stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Not device related.
Frequency: 1 affected / 73 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related. Worsening dyspnea on exertion. Cardiac catheter and stent placement. History of coronary artery disease.
Frequency: 1 affected / 73 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related. History of interstitial lung disease.
Frequency: 1 affected / 73 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related.
Frequency: 1 affected / 73 at risk

Adverse event: Worsening degenerative joint disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not device related. Worsening degenerative joint disease of bilateral hips.
Frequency: 1 affected / 73 at risk

Adverse event: Vaginal Mucosal Wall Injury
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Abrasion, bleeding, erythema, petechia, ecchymosis, hyperemia, or erosion of vaginal tissue apparent during pelvic examination.
Frequency: 10 affected / 73 at risk

Adverse event: Lower Urinary Tract Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: New or increased urinary incontinence or voiding difficulty or urinary frequency, urinary tract infections, or dysuria.
Frequency: 7 affected / 73 at risk

Adverse event: Vaginal/Pelvic Discomfort/Irritation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vaginal/Pelvic discomfort, pain, irritation, discharge, odor, burning sensation, or itching.
Frequency: 11 affected / 73 at risk

Adverse event: Vaginal Infections
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Yeast infection of the vagina or unspecified vaginitis. Does not include systemic yeast infections or infections of other areas that do not affect the vagina.
Frequency: 5 affected / 73 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 2 affected / 73 at risk