MAUDE Adverse Event Report: Inspire Medical Systems Inspire Model 4063 Stimulation Lead

Model Number	4063Si
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with redness and drainage at the neck incision site.Cultures were obtained, and the results were positive for infection.Physician prescribed multiple courses of antibiotics and referred the patient to an infectious disease specialist for further evaluation.

• Brand Name: Inspire Model 4063 Stimulation Lead
• Common Device Name: Inspire Model 4063 Stimulation Lead
• 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: 50009294
• Report Number: 3007666314-2026-01415
• Device Sequence Number: 5841580
• Product Code: MNQ
• UDI-Device Identifier: 10855728005793
• UDI-Public: 10855728005793
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 4063Si
• Device Catalogue Number: 900-013-001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/27/2026
• 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