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 Codes	Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with redness around the ipg site, which was slightly raised.Due to a potential infection and seroma, the physician prescribed antibiotics.Patient presented back to the physician with continued issues at the ipg site, and the wound was not healing properly.No infection was confirmed upon examination.Physician opened the chest pocket in clinic, drained the clear fluid, performed a washout procedure, and closed.Physician prescribed an additional course of antibiotics.

• 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 ; 7632057970
• MDR Report Key: 25554165
• Report Number: 3007666314-2026-01346
• Device Sequence Number: 5560511
• Product Code: MNQ
• UDI-Device Identifier: 10855728005915
• UDI-Public: 10855728005915
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 08/26/2026
• 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