Study: NCT00572195

Adverse event: EEG monitoring
Serious: yes
Organ System: Investigations
Frequency: 44 affected / 230 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 230 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 230 at risk

Adverse event: Tonic-clonic seizures increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 230 at risk

Adverse event: Brain lobectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 11 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 230 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 230 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 230 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 230 at risk

Adverse event: Implant site erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 230 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 230 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 230 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 230 at risk

Adverse event: Postictal state
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 230 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 230 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 230 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 230 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 230 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 230 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 230 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 230 at risk

Adverse event: Live birth
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 230 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 230 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 230 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 230 at risk

Adverse event: Angiogram cerebral
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 230 at risk

Adverse event: Device lead revision
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 230 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 230 at risk

Adverse event: Lumbar vertebral fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 230 at risk

Adverse event: Investigation
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 230 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 230 at risk

Adverse event: Skin laceration (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 230 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 230 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 230 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 230 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 230 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 230 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 230 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 230 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 230 at risk

Adverse event: Cranioplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 230 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 230 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 230 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 230 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 230 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 230 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 230 at risk

Adverse event: Mammoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 230 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 230 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 230 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 230 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 230 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 230 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 230 at risk

Adverse event: Head injury (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Hip fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 230 at risk

Adverse event: Intracranial hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Jaw fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Postictal paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Road traffic accident (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Subdural haematoma (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 230 at risk

Adverse event: Thermal burn (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 230 at risk

Adverse event: Traumatic intracranial haemorrhage (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 230 at risk

Adverse event: Implant site infection (dts)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 230 at risk

Adverse event: Tracheostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Vasectomy reversal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Victim of crime
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 230 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Wrist fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Premature battery depletion (GB-2570)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Premature battery depletion (RE-CR2450N)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Device extrusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Device electrical finding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Implant site discharge
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Procedural vomiting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Stitch abscess
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Simple partial seizures increased (sensory)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Incision site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Intraventricular haemorrhage (dts)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Keloid scar
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Lower limb fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Lumbar puncture
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 230 at risk

Adverse event: Medical device implantation (LR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Medical device removal (LR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Melanocytic naevus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Menicus lesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Menstrual disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Nasal congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Neuromyelitis optica spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pelvic congestion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pelvic fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Post lumbar puncture syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Postoperative respiratory distress
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Rectal discharge
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Renal cell carcinoma state unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Simple partial seizures increased (motor)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Skeletal injury (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Somatic delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Spinal fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Subarachnoid haemorrhage (dts)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Mandibular mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Tendon disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Tooth impacted
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Toothache
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Tracheal obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Adenoma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Ankle fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Anticonvulsant drug level below therapeutic
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 230 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Arrhthmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Aspiration (dts)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Breast enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Breast reconstruction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Cervical cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 230 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Clavicle fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Contusion (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Conversion disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Drug withdrawal headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Endodontic procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 230 at risk

Adverse event: Epileptic psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Face injury (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Facial bones fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Fall (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Feeling cold
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Focal segmental glomerulosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Fractured skull depressed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Gastrinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hand fracture (dts)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 115 affected / 230 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 71 affected / 230 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 69 affected / 230 at risk

Adverse event: EEG monitoring
Serious: no
Organ System: Investigations
Frequency: 44 affected / 230 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 230 at risk

Adverse event: Skin laceration (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 230 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 230 at risk

Adverse event: Contusion (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 230 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 230 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 230 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 230 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 230 at risk

Adverse event: Procedural pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 230 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 230 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 230 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 230 at risk

Adverse event: Tonic-clonic seizures increased
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 230 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 230 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 230 at risk

Adverse event: Vitamin D abnormal
Serious: no
Organ System: Investigations
Frequency: 18 affected / 230 at risk

Adverse event: Joint injury (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 230 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 230 at risk

Adverse event: Tonic-clonic seizures exacerbated
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 230 at risk

Adverse event: Head injury (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 230 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 230 at risk

Adverse event: Multiple injuries (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 230 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 230 at risk

Adverse event: Simple partial seizures (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 230 at risk

Adverse event: Postictal state
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 230 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 230 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 230 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 230 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 230 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 230 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 230 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 230 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 230 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 230 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 230 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 230 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 230 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 230 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 230 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 230 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 230 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 230 at risk

Adverse event: Brain lobectomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 230 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 230 at risk

Adverse event: Temor
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Photopsia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Simple partial seizures (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 230 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 230 at risk

Adverse event: Excoriation (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 230 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 230 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 230 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 9 affected / 230 at risk

Adverse event: Fall (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 230 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 230 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 230 at risk

Adverse event: Medical device removal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 230 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 230 at risk

Adverse event: Thermal burn (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 230 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 230 at risk

Adverse event: Status epilepticus
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 230 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 230 at risk

Adverse event: Implant site erosion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 230 at risk

Adverse event: Limb injury (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 230 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 230 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 230 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 230 at risk

Adverse event: Simple partial seizures increased (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 230 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 230 at risk

Adverse event: Depression suicidal
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 230 at risk

Adverse event: Device interaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 230 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 230 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 230 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 230 at risk

Adverse event: Status epilepticus
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 230 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 230 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 230 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 230 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 230 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 230 at risk

Adverse event: Clavicle fracture (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 230 at risk

Adverse event: Conversion disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 230 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 230 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 230 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 230 at risk

Adverse event: Hernia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 230 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 230 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 230 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 230 at risk

Adverse event: Road traffic accident (dts)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 230 at risk

Adverse event: Simple partial seizures increased (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 230 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 230 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 230 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 230 at risk