An article was received that reported multiple adverse events and a malfunction.The current report captures the adverse events associated with the generator.Mfr.Report # 1644487-2017-04155 captures the malfunctions reported by the article.Mfr.Report # 1644487-2017-04154 captures adverse events associated with the lead.There was one intraoperative adverse event associated with the generator.This patient experienced transient asystole intraoperatively.This event resolved without treatment and did not require cardiopulmonary resuscitation.There were three reported post-surgical complications related to the generator.There was one patient that presented with wound dehiscence one week post-surgery that was managed surgically.Another patient presented with an infection at both generator and neck sites; this patient had full recovery after being treated aggressively, first with iv antibiotics for one week and second with oral antibiotics for another week.The last patient experienced post-operative status epilepticus that required 3 days intubation and icu admission; this was most probably related to general anesthesia used during surgery.The article reported that 10 patients experienced laryngeal side effects associated with stimulation (coughing, hoarseness and shortness of breath) that were proportional to amplitude, frequency and duration of stimulation.These patients all presented with a significant increase in vocal handicap index.These patients were found to have decreased left cord mobility that was more significant with vocal cord abduction.The left cord in the resting position was shorter and more medially-positioned than the right vocal cord.None had complete vocal cord paralysis and their voice changes did not affect their ability to communicate and shortness of breath was mild.None needed medical or surgical treatment.Vocal hoarseness resolved in patient's no longer receiving therapy.One patient experienced an increase in seizures with vns therapy.The patient' caregivers requested vns removal.No further relevant information has been received to date.
|