Study: NCT02647905

Adverse event: Surgical procedure to remove sensor
Serious: yes
Organ System: Surgical and medical procedures
Notes: PI requested assistance from a general surgeon for removal of sensor through outpatient surgery who then elected to place the patient under general anesthesia. The sensor was removed intact without incident
Frequency: 1 affected / 90 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Notes: Related or Possibly related to Study Procedure
Frequency: 2 affected / 90 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Nervous system disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related or Possibly related to Study Procedure
Frequency: 4 affected / 90 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Syncope-Vasovagal
Serious: no
Organ System: Vascular disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 2 affected / 90 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Broken toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Chest injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Sensor location site- Pain/discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Candidiasis vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 4 affected / 90 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 2 affected / 90 at risk

Adverse event: Cracked tooth
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Infection-Tooth
Serious: no
Organ System: Infections and infestations
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Infection-Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Blepharoplasty
Serious: no
Organ System: Surgical and medical procedures
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Broken tooth
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: TMJ pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Device Fragement not recovered
Serious: no
Organ System: Surgical and medical procedures
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 2 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Erythema, removal site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Sensor location site- Pain/discomfort
Serious: no
Organ System: General disorders
Notes: Related or Possibly related to the study device or Insertion/Removal Procedure
Frequency: 3 affected / 90 at risk

Adverse event: IV site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related or Possibly related to Study Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Immune system disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: IV site Erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related or Possibly related to Study Procedure
Frequency: 1 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 4 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 2 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to Study device or insertion/removal procedure
Frequency: 2 affected / 90 at risk

Adverse event: Erythema, Arm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related or Possibly related to Study Procedure
Frequency: 1 affected / 90 at risk