Study: NCT01198470

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 20 at risk

Adverse event: Gastric bypass to convert Lap Band
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache and fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Intrauterine Growth Restriction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dural tear
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysesthesia - lower extremities
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Weakness in bilateral legs
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dural tear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pain - back and hip
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain - back and lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - hip
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - lower extremities
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain - lower extremities with dysesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - neck and/or upper extremities
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Wound issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Seizure type incidents
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Dysesthesia - lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Paresthesia - lower extremities
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk