Study: NCT03131960

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Patient with history of seizures had one during the 5th week of study treatment. Admitted to the ICU, recovered, was discharged, and continued in the study. The device implant and device stimulation are not related to this event (patient history).
Frequency: 1 affected / 53 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subject hospitalized with urinary tract infection. Subject recovered and continued in the study. No relationship to implant surgery or stimulation.
Frequency: 1 affected / 53 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 Subject fell at home walking down steps; fractured two vertebrae. 1 Subject fell at hospital during testing. 1 subject fell at home and broke her humerus. Subjects missed visits but continued in the study. No relationship to surgery or therapy.
Frequency: 2 affected / 53 at risk

Adverse event: Colinic Diverticular Abscess
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject reported pain and achiness at home. ER assessment indicated CDA. CDA drained and antibiotics started; subject returned home and recovered. No relationship to device implant or stimulation.
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Coughing/Hoarseness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 53 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 53 at risk

Adverse event: Acute Kidney Injury (AKI)/ chronic kidney disease (CKD)
Serious: yes
Organ System: Renal and urinary disorders
Notes: The patient was hospitalized after 7-8 months of worsening swelling and dyspnea on exertion (pre study). Found to have acute onset kidney injury (AKI on Chronic Kidney Disease \[CKD\]). Patient recovered and continued. Not related to implant or stim.
Frequency: 1 affected / 55 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject experienced vocal cord paresis and dysphonia after surgery. Recovered over 5 weeks; laryngoscope confirmed complete recovery. Related to the implant procedure but not stimulation. Subject recovered and continued in the study.
Frequency: 1 affected / 55 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 Subject fell at home walking down steps; fractured two vertebrae. 1 Subject fell at hospital during testing. 1 subject fell at home and broke her humerus. Subjects missed visits but continued in the study. No relationship to surgery or therapy.
Frequency: 1 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 55 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 55 at risk

Adverse event: Coughing/Hoarseness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 55 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 55 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 55 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 55 at risk