MAUDE Adverse Event Report: Inspire Medical Systems Inspire Model 3028 IPG; Stimulator, Hypoglossal Nerve, Implanted, Apnea

Model Number	3028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Implant Pain (4561)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional details were received after the submission of the initial mdr report number (b)(4).The patient presented to the physician in (b)(6) 2025 with erythema and swelling at the chest incision site, and antibiotic treatment was initiated.Diagnostic testing revealed that the white blood cell count, erythrocyte sedimentation rate (esr), and c-reactive protein (crp) levels were within normal limits.Based on these findings, no concerns for infection were noted.
Event or Problem Description
Patient presented to the physician with a raised ipg site, redness, warmth, and pain.Due to concern for a possible infection, the physician prescribed antibiotics.

• Brand Name: Inspire Model 3028 IPG
• Common Device Name: Stimulator, Hypoglossal Nerve, Implanted, Apnea
• Manufacturer (Section D): Inspire Medical Systems; 5500 wayzatablvd.; suite 1600; golden valley MN 55416
• Manufacturer (Section G): Inspire Medical Systems; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer Contact: vang yang ; 5500 wayzata blvd.; suite 1600; golden valley, MN 55416 ; +1(763)205-7970
• MDR Report Key: 50059985
• Report Number: 3007666314-2026-01431
• Device Sequence Number: 10687378
• Product Code: MNQ
• UDI-Device Identifier: 10855728005915
• UDI-Public: 10855728005915
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3028
• Device Catalogue Number: 900-007-014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown