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  • Author
    Nikhil Bellamkonda
  • Co-author

    Nikhil Bellamkonda, BS; Travis Shiba, MD; Abie Mendelsohn, MD

  • Title

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

  • Abstract


    Hypoglossal nerve stimulator implantation offers a novel surgical treatment of multilevel airway collapse during obstructive sleep apnea. A better understanding of the causes and impact of adverse events on patients undergoing stimulator implantation is critical to improvement patient preparation and avoid future surgical 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.


    The MAUDE database was searched for reports containing the terms ‘hypoglossal nerve stimulator’ and ‘Inspire’, which is currently the only FDA approved system for upper airway stimulation for OSA. The search was limited to events occurring between May 2014 and September 2019. 


    A total of 132 patient reports were identified over the five-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 two 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. 


    Previous data has demonstrated reliable efficacy of hypoglossal nerve stimulator implantation for OSA. However, there are several complications seen in the perioperative period which should be discussed with patients during the surgical consent process. 

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