LAUSR

This investigation analyzes adverse event reports (AERs) from the FDA MAUDE database for Continuous Positive Airway Pressure (CPAP), Hypoglossal Nerve Stimulation (HNS) and Oral Appliance Therapy (OAT) devices. The FDA defines adverse events as undesirable experiences associated with medical devices that should be reported when the outcome is death, life threatening, hospitalization, disability, required intervention, or serious medical events. Publicly available industry reports were utilized to estimate prevalence of AERs. From January 1, 2022 to September 2022, AERs for CPAP, HNS and OAT were 72,251, 11,867 and 30, respectively. From January 2017 to September 2022, the annual count of AERs for CPAP and HNS increased 245% and 252% respectively. The annual count of AERs for OATs decreased -1.3% over the same period. Device Problems For CPAP, “Degradation” comprised 96.6% of the AERs. For HNS, “Event Without Problem” and “Device Sensing” comprised 78.6% and 11.0% of AERs respectively. For OAT “Event without Identification” and “Breakage” comprised 40.0% and 9.8% of AERs respectively. Patient Problems For CPAP, seven patient problems comprise over 80% of reports: No Clinical Signs/Conditions, 57.3%; Dyspnea, 5.4%; Headache, 5.3%; Sore Throat, 4.3%; Respiratory Tract Infection, 4.1%; Cough, 3.5%; Unspecified Respiratory, 3.0%. For HNS, nine patient problems comprise over 80% of reports: Unspecified Infection, 19%; Pain, 15.2%; No Clinical Conditions, 9.2%; Bacteria Infection, 8.7%; Perforation of Vessels, 7.1%; Erosion, 7.1%; Wound Dehiscence, 4.9%; Swelling/Edema, 4.8%; Hematoma, 4.4%. For OAT, seven patient problems comprise over 80% of reports: Hypersensitivity/Allergic Reaction, 23.5%; Reaction, 19.0%; No Known Impact, 15.9%; Swelling, 8.7%; Pain, 6.2%; Discomfort, 4.5%; Erythema, 3.8%; Rash, 3.5%. This analysis suggests that healthcare providers may wish to consider the significant differences in the frequencies and the severities of adverse events when prescribing treatment modalities for patients with OSA. Dental side effects, a widely referenced reason for limiting the utilization of OAT devices, do not show up in the top 80% of the most frequently reported types of adverse events.