Study: NCT02989610

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Traumatic Psoas Bleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Endocrinological Issues
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 234 at risk

Adverse event: Appendicitis with Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Coma Related to Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Fall at Home
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Fracture of Vertebrae
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Several Falls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Spinal Cord Canal Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: TLOC (Transient Loss of Consciousness)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Sepsis Secondary to Influenza Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 234 at risk

Adverse event: Battery Failure Within the Device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 234 at risk

Adverse event: Extension Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Loss of Therapeutic Benefit - Change in Electrode Positions
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Speech or Language Impairment - Aphasia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Speech or Language Impairment - Dysphagia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Basal Cell Carcinoma of Scalp and Squamous Cell Carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Cognitive impairment - Confusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Cognitive impairment - Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Dopamine dysregulation syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 234 at risk

Adverse event: Renal Stones with Secondary Sepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 234 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 234 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Erosion Due to Undiagnosed Dermatologic Disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Bioprosthetic Av Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 234 at risk

Adverse event: Battery Failure Within the Device
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 234 at risk

Adverse event: Cognitive Impairment - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Cognitive Impairment - Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 234 at risk

Adverse event: Cognitive Impairment - Hallucinations
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Decreased Therapeutic Response
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 234 at risk

Adverse event: Deep Brain Stimulation System Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 234 at risk

Adverse event: Dyskinetic Dystonia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Dystonia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Impaired Wound Healing - Incision Site Drainage
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 234 at risk

Adverse event: Loss of Therapeutic Benefit - Change in Loose Electrical Connections
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Persistent Pain at Surgery Site or Ipg Site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 234 at risk

Adverse event: Sensory Disturbance or Impairment - Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Sensory Disturbance or Impairment - Sensory Deficit
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 234 at risk

Adverse event: Shortness of Breath On Exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Skull Discoloration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Speech or Language Impairment - Dysarthria
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Sub-Optimal Placement of Lead
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Undesirable Changes in Stimulation - Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Bradykinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Motor Fluctuations
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Rigidity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 234 at risk

Adverse event: Worsening of Motor/Parkinson's Disease Symptoms - Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 234 at risk