Study: NCT00640133

Adverse event: Symptom worsening
Serious: yes
Organ System: Nervous system disorders
Notes: Mood liability alternating between irritable, anger and sad, worsening to SI hurting self and wanting to die.
Frequency: 1 affected / 15 at risk

Adverse event: Motor effect (fall)
Serious: yes
Organ System: Nervous system disorders
Notes: Patient rolled out of bed and hit head. Went to ER, received 6 stitches on scalp.
Frequency: 1 affected / 15 at risk

Adverse event: Periorbital swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient went to ER due to periorbital swelling.
Frequency: 1 affected / 15 at risk

Adverse event: Symptom worsening
Serious: no
Organ System: Nervous system disorders
Notes: Including increased anxiety, OCD, depression,
Frequency: 4 affected / 15 at risk

Adverse event: Hypomania
Serious: no
Organ System: Nervous system disorders
Notes: Hypomania also including "elevated mood"
Frequency: 1 affected / 15 at risk

Adverse event: Alcohol-related event
Serious: no
Organ System: Nervous system disorders
Notes: Fight and shoulder pain from drunken fall.
Frequency: 1 affected / 15 at risk

Adverse event: Post-surgical discomfort/pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Discomfort/pain/numbness after surgery
Frequency: 2 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post-surgical infection
Frequency: 2 affected / 15 at risk

Adverse event: Pocket stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Side effect of the device.
Frequency: 1 affected / 15 at risk

Adverse event: GI discomfort/symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI discomfort including diarrhea, abdominal pain, and bleeding
Frequency: 1 affected / 15 at risk

Adverse event: Headache/migraine
Serious: no
Organ System: Nervous system disorders
Notes: Headache/migraine (including chronic)
Frequency: 1 affected / 15 at risk

Adverse event: Tiredness/severe fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Tiredness up to severe fatigue
Frequency: 2 affected / 15 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: New infection, "boil," developed at implant site and expelled pus and blood.
Frequency: 1 affected / 12 at risk

Adverse event: Symptom worsening
Serious: no
Organ System: Nervous system disorders
Notes: Including increased anxiety, OCD, depression,
Frequency: 4 affected / 12 at risk

Adverse event: Hypomania
Serious: no
Organ System: Nervous system disorders
Notes: Hypomania also including "elevated mood"
Frequency: 2 affected / 12 at risk

Adverse event: Post-surgical discomfort/pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Discomfort/pain/numbness after surgery
Frequency: 1 affected / 12 at risk

Adverse event: GI discomfort/symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI discomfort including diarrhea, abdominal pain, and bleeding
Frequency: 3 affected / 12 at risk

Adverse event: Headache/migraine
Serious: no
Organ System: Nervous system disorders
Notes: Headache/migraine (including chronic)
Frequency: 2 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 1 affected / 12 at risk