Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database

• Published in: Otolaryngology-head and neck surgery 2021-02, Vol.164 (2), p.443-447
• Main Authors: Bellamkonda, Nikhil, Shiba, Travis, Mendelsohn, Abie H.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Databases, Factual; Electric Stimulation Therapy - adverse effects; Electrodes, Implanted - adverse effects; Equipment Failure; Female; Follow-Up Studies; Humans; Hypoglossal Nerve - physiopathology; Inspire; Male; Middle Aged; obstructive sleep apnea; Retrospective Studies; Sleep Apnea, Obstructive - therapy; Time Factors; United States; United States Food and Drug Administration - statistics & numerical data; upper airway stimulation
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1177/0194599820960069

Objective Use of hypoglossal nerve stimulator implantation has dramatically improved the surgical treatment of multilevel airway collapse during obstructive sleep apnea (OSA). Understanding causes of adverse events and their impact on patients undergoing stimulator implantation will help improve patient preparation and surgical practices to avoid future complications. Study Design This study is a retrospective review of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, a publicly available voluntary reporting system. Setting National patient event database. Methods The MAUDE database was searched for reports associated with the terms “hypoglossal nerve stimulator” and “Inspire,” being the only currently FDA-approved system for upper airway stimulation for OSA. All records were searched with the events limited in dates between May 2014 and September 2019. Results A total of 132 patient reports were identified over the 5-year inclusion period, containing 134 adverse events. The reported adverse events resulted in 32 device revision procedures as well as 17 explantations. Device migration and infection were 2 of the most commonly reported adverse events. Complications not witnessed in previous large-scale clinical trials included pneumothorax, pleural effusion, and lead migration into the pleural space. Conclusion Previous data have demonstrated hypoglossal nerve stimulator implantation results in reliable OSA improvement. However, a number of technical difficulties and complications still exist during the perioperative period, which should be communicated to patients during the surgical consent process.