Study: NCT00264810

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 97 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Angiogram cerebral
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 97 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Blindness transient
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Central venous catheterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 97 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 97 at risk

Adverse event: Contraception
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 97 at risk

Adverse event: Conversion disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 97 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 97 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 97 at risk

Adverse event: Device lead revision
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 97 at risk

Adverse event: EEG monitoring
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 97 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hand fracture (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Head injury (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Implant site discharge
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Implant site infection (due to seizure)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Intracranial hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Laceration (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Live birth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 97 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 97 at risk

Adverse event: Medical device removal (VNS)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 97 at risk

Adverse event: Meningioma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Menstrual disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 97 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 97 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 97 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Postictal state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 97 at risk

Adverse event: Procedural headache
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Procedural vomiting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Skin laceration (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Subdural haematoma (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Tonic-clonic seizures increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 97 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 97 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 97 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 97 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 12 affected / 97 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 97 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 97 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Back injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 97 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 97 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 97 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 97 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 97 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 97 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Contusion (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 97 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 97 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 97 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 97 at risk

Adverse event: Device interaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 97 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 97 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 97 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 97 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 97 at risk

Adverse event: Excoriation (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 97 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 97 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 97 at risk

Adverse event: Head injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 97 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 97 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 41 affected / 97 at risk

Adverse event: Implant site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 97 at risk

Adverse event: Implant site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 97 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 97 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 97 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 97 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Joint injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Limb injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 97 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 97 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Monoparesis
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Multiple injuries (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 97 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 97 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 97 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 97 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 97 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 97 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Photopsia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 97 at risk

Adverse event: Postictal state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Post procedural constipation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Post procedural fever
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 97 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 97 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 97 at risk

Adverse event: Simple partial seizures (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: Simple partial seizures (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 97 at risk

Adverse event: Simple partial seizures exacerbated (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Simple partial seizures exacerbated (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Simple partial seizures increased (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Simple partial seizures increased (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 97 at risk

Adverse event: Skin laceration (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 97 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 97 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 97 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 97 at risk

Adverse event: Tongue injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 97 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 97 at risk

Adverse event: Tonic-clonic seizures increased
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 97 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 97 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 97 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 97 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 97 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 97 at risk

Adverse event: Acquired epileptic aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Apraxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Atonic seizures increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Benign breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 94 at risk

Adverse event: Biopsy brain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 94 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 94 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 94 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 94 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 94 at risk

Adverse event: Device lead revision
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 94 at risk

Adverse event: Dysphemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: EEG monitoring
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 94 at risk

Adverse event: Epileptic psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Hip fracture (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 94 at risk

Adverse event: Implant site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Implant site erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 94 at risk

Adverse event: Implant site infection (due to seizure)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Jaw fracture (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Medical device removal (VNS)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 94 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 94 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 94 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Postictal state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Procedural headache
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Shoulder operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Simple partial seizures (sensory)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Simple partial seizures exacerbated (motor)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Simple partial seizures increased (motor)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Simple partial seizures increased (sensory)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Skin laceration (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Skin neoplasm excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Tendon transfer
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Thermal burn (due to seizure)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 94 at risk

Adverse event: Tonic-clonic seizures increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 94 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Toothache
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 94 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 18 affected / 94 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 94 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 94 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Back injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 94 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 94 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 94 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 94 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 94 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 94 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 94 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 94 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 94 at risk

Adverse event: Contusion (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 94 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 94 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 94 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 94 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 94 at risk

Adverse event: Device interaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 94 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 94 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 94 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 94 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 94 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 94 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 94 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 94 at risk

Adverse event: Excoriation (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 94 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 94 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 94 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 94 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 94 at risk

Adverse event: Head injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 94 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 94 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 94 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 94 at risk

Adverse event: Implant site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 94 at risk

Adverse event: Implant site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 94 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 94 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 94 at risk

Adverse event: Joint injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 94 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Limb injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 94 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 94 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 94 at risk

Adverse event: Monoparesis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Multiple injuries (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 94 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 94 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 94 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 94 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 94 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 94 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 94 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 94 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 94 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 94 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 94 at risk

Adverse event: Photopsia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 94 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 94 at risk

Adverse event: Postictal state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 94 at risk

Adverse event: Post procedural constipation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 94 at risk

Adverse event: Post procedural fever
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 94 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 94 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 94 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 94 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Simple partial seizures (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 94 at risk

Adverse event: Simple partial seizures (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 94 at risk

Adverse event: Simple partial seizures exacerbated (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Simple partial seizures exacerbated (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Simple partial seizures increased (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Simple partial seizures increased (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 94 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 94 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 94 at risk

Adverse event: Skin laceration (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 94 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 94 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 94 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 94 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 94 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 94 at risk

Adverse event: Tongue injury (due to seizure)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 94 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 94 at risk

Adverse event: Tonic-clonic seizures increased
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 94 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 94 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 94 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 94 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 94 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 94 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 94 at risk