Daniel E Bestourous1, Luke J Pasick2, Daniel A Benito3, Philip E Zapanta3. 1. Division of Otolaryngology-Head & Neck Surgery, George Washington University School of Medicine & Health Sciences, Washington, DC, United States of America. Electronic address: bestourous@gwu.edu. 2. Department of Otolaryngology-Head & Neck Surgery, University of Miami Miller School of Medicine, Miami, FL, United States of America. 3. Division of Otolaryngology-Head & Neck Surgery, George Washington University School of Medicine & Health Sciences, Washington, DC, United States of America.
Abstract
BACKGROUND: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. OBJECTIVE: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. METHODS: A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. RESULTS: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). CONCLUSION: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.
BACKGROUND: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. OBJECTIVE: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. METHODS: A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. RESULTS: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). CONCLUSION: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.
Authors: Saif Mashaqi; Salma Imran Patel; Daniel Combs; Lauren Estep; Sonia Helmick; Joan Machamer; Sairam Parthasarathy Journal: Int J Environ Res Public Health Date: 2021-02-09 Impact factor: 3.390