Study: NCT03082261

Adverse event: Acute Respiratory Failure with Flash Pulmonary Edema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Allergic or Rejection Response to Implant Materials
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Changes in Stimulation or Reduced Pain Relief Due to Lead Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 269 at risk

Adverse event: Keloid Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Pain Below the Level of Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Persistent Pain at The IPG Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Skin Erosion Around the Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Skin Irritation at IPG Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Stimulation in Unwanted Places/Chest Wall Stimulation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Weakness, Clumsiness, Numbness or Pain Below the Level of Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 269 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cellulitis of Left Upper Extremity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Cerebral Infarction Due to Embolism of Unspecified Cerebral Artery
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Death of Unknown Cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Staph Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Suicide Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 269 at risk

Adverse event: Syncope and Bleeding After Colonoscopy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Broken Swift Lock Anchors
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Burning Pain at The IPG Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Cerebrospinal Fluid (CSF) Leakage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Changes in Stimulation or Reduced Pain Relief Due to Lead Failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 269 at risk

Adverse event: Changes in Stimulation or Reduced Pain Relief Due to Lead Migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 269 at risk

Adverse event: Changes in Stimulation or Reduced Pain Relief Due to Loose Electrical Connections
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Chronic Pain Exacerbation Due to Battery Depletion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Damage to Functionality/ Mechanical Integrity of IPG Resulting in Inability to Communicate with IPG
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Damage to IPG/Leads Causing System Fail Deliver Stimulation/Causing System Deliver Overstimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Inadequate Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Increased Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 269 at risk

Adverse event: Insufficient Pain Relief
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Persistent Pain at The IPG Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 269 at risk

Adverse event: Persistent Pain at The Lead Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Stimulation in Unwanted Places/Chest Wall Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Undesirable Changes in Stimulation Which May Be Due to Cellular Changes in Tissue Around Electrodes
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Weakness, Clumsiness, Numbness or Pain Below the Level of Implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk