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

Model Number	3028
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pocket Erosion (2013); Medical device site infection (4845)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with wound dehiscence at the chest incision site.Upon examination, a superficial infection was also suspected.Physician irrigated and drained the chest incision site, covered the wound, and prescribed antibiotics.Patient presented back to the physician with continued wound dehiscence and infection, and it was noted that the ipg was beginning to protrude through the chest incision site.Physician brought the patient into the or, explanted the ipg and sensing lead, removed a portion of the stimulation lead, and closed.Postoperative antibiotics were prescribed after the procedure was completed.

• 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: 25535152
• Report Number: 3007666314-2026-01343
• Device Sequence Number: 21236736
• Product Code: MNQ
• UDI-Device Identifier: 10855728005915
• UDI-Public: 10855728005915
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/17/2026

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: 06/03/2026
• Initial Report FDA Received Date: 06/17/2026
• 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