Study: NCT01772693

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Notes: After Focused Ultrasound Surgery thalamotomy procedure. Determined event to be SAE related to thalamotomy.
Frequency: 2 affected / 20 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: Event 1 component was mild right-sided hemiparesis (weakness) with drift. Event expected and related to thalamotomy. Resolved.
Frequency: 1 affected / 20 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to device or procedure
Frequency: 1 affected / 20 at risk

Adverse event: Degenerative knee disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device or procedure. Subject had knee replacement and physical therapy. Adverse event resolved.
Frequency: 1 affected / 20 at risk

Adverse event: Worsening depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Since his tremor was gone he stopped his dopamine antagonist and he also stopped his antidepressants. His physicians planned to re-instate antidepressant medications and neuropsychology treatment.
Frequency: 1 affected / 20 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Notes: Related to Parkinson's Disease progression.
Frequency: 1 affected / 20 at risk

Adverse event: Tremor worsened
Serious: no
Organ System: Nervous system disorders
Notes: Related to Parkinson's Disease progression
Frequency: 1 affected / 20 at risk

Adverse event: Fatique
Serious: no
Organ System: General disorders
Notes: Procedure related
Frequency: 2 affected / 20 at risk

Adverse event: Musculoskeletal weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Procedure related
Frequency: 1 affected / 20 at risk

Adverse event: Dysgnosia
Serious: no
Organ System: Nervous system disorders
Notes: Procedure related
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Procedure related
Frequency: 1 affected / 20 at risk

Adverse event: Dysmetria
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Thalamotomy related
Frequency: 1 affected / 20 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Thalamotomy related
Frequency: 2 affected / 20 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Imbalance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Thalamotomy related
Frequency: 4 affected / 20 at risk

Adverse event: Dysmetria
Serious: no
Organ System: Nervous system disorders
Notes: Thalamotomy related
Frequency: 2 affected / 20 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Notes: Thalamotomy related
Frequency: 2 affected / 20 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Notes: Thalamotomy related
Frequency: 7 affected / 20 at risk

Adverse event: Unsteady
Serious: no
Organ System: Nervous system disorders
Notes: Thalamotomy related
Frequency: 1 affected / 20 at risk

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

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Sonication related flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Eye disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Transient
Frequency: 5 affected / 20 at risk

Adverse event: Imbalance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Positional pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Transient
Frequency: 3 affected / 20 at risk

Adverse event: Imbalance
Serious: no
Organ System: Nervous system disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Transient
Frequency: 2 affected / 20 at risk

Adverse event: Dysgnosia
Serious: no
Organ System: Psychiatric disorders
Notes: Transient
Frequency: 2 affected / 20 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Notes: Transient
Frequency: 5 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Transient
Frequency: 11 affected / 20 at risk

Adverse event: Sonication related scalp pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient
Frequency: 1 affected / 20 at risk

Adverse event: Sonication related head pain
Serious: no
Organ System: General disorders
Notes: Transient
Frequency: 5 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Transient
Frequency: 7 affected / 20 at risk

Adverse event: Pigment change in eye
Serious: no
Organ System: Eye disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Vision change
Serious: no
Organ System: Eye disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Vocal change
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Worsening depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Positional pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Cerebelar infarct
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Facial edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 3 affected / 20 at risk

Adverse event: Pin site numbness/tingling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Pin site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 3 affected / 20 at risk

Adverse event: Stereotactic frame bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 20 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Notes: The Data Safety Monitoring Board discussed the event, the subject's symptoms and the lack of imaging findings and determined that they agreed with the investigator that this event was Unrelated to the Exablate procedure.
Frequency: 1 affected / 7 at risk

Adverse event: Dysgnosia
Serious: no
Organ System: Nervous system disorders
Notes: Related to Parkinson's Disease progression
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Procedure related
Frequency: 1 affected / 7 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Transient
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Transient
Frequency: 2 affected / 7 at risk

Adverse event: Sonication related head pain
Serious: no
Organ System: General disorders
Notes: Transient
Frequency: 1 affected / 7 at risk

Adverse event: Pin Site Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient
Frequency: 1 affected / 7 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Pin site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 7 at risk