MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG

Model Number	3028
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with movement and flipping of the ipg within the pocket, causing stimulation lead tethering, discomfort, and swelling at the neck incision site down to the chest.Physician brought the patient into the or, explanted the entire inspire system, irrigated the ipg pocket with antibiotic solution, and closed.

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: INSPIRE MODEL 3028 IPG
• 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 ; 7632057970
• MDR Report Key: 25377635
• Report Number: 3007666314-2026-01310
• Device Sequence Number: 18805267
• Product Code: MNQ
• UDI-Device Identifier: 10855728005915
• UDI-Public: 10855728005915
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 05/21/2026
• Initial Report FDA Received Date: 06/03/2026
• 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