Study: NCT00617162

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 60 at risk

Adverse event: Elective admission to IP unit to alleviate burden on primary carer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Patient re-admitted on an elective basis to IP unit
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 60 at risk

Adverse event: Post-operative discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Seizure or convulsion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Suicide or suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 60 at risk

Adverse event: Increase in depressive symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 60 at risk

Adverse event: Hearing and visual disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 60 at risk

Adverse event: General erosion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 60 at risk

Adverse event: Feeling hot constant
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Feeling cold constant
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Mild worsening of pre-existing tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nocturia with urinary frequency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Leg cramps and soreness on legs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Motor incoordination left side
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Mild tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ridge right side of scalp with twinges of pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Burned self left deltoid area
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Back pain from carrying heavy load of water
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Patient claims she can "feel the wires in brain"
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Reports of increased cravings for chocolate and biscuits
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Complaining of aches and pains and cramps in hands, arms, and feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Post operative discomfort
Serious: no
Organ System: General disorders
Frequency: 5 affected / 60 at risk

Adverse event: Procedural pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Subcutaneous hemorrhage or seroma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Aphasia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pulling sensation along extension site
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Persistent pain or redness at the IPG site or surgery site/extension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hearing and visual disturbance
Serious: no
Organ System: General disorders
Frequency: 9 affected / 60 at risk

Adverse event: Disequilibrium
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Increase in depressive symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Eye disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Neuralgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 60 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Skin disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: General erosion or local skin erosion over the IPG, burr hold cap, and/or extension
Serious: no
Organ System: General disorders
Frequency: 9 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Increase in drug side effects
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Myoclonus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Asthenia, hemiplegia, or hemiparesis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Attention deficit
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Bariatric weight loss surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Seizure or convulsion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Suicide or suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Increase in depressive symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Middle back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Generalized body pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperphagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cutting self
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fractured arm
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Feeling of surgical pressure on IPG site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Churning feeling in the head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Occasional, very mild tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Unilateral eye swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pustule on suture line
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Post operative discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Procedural pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Subcutaneous hemorrhage or seroma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Pulling sensation along extension site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Persistent pain or redness at the IPG site or surgery site/extension
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Cerebrospinal fluid abnormality
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Disequilibrium
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increase in depressive symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Eye disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Skin disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: General erosion or local skin erosion over the IPG, burr hold cap, and/or extension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Suicide or suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rapid heart rate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Increase in drug side effects
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk