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	Headache (1880)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with persistent headaches.Physician prescribed medication to manage the symptoms.

• 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: 50455575
• Report Number: 3007666314-2026-01505
• Device Sequence Number: 10050397
• Product Code: MNQ
• UDI-Device Identifier: 10855728005793
• UDI-Public: 10855728005793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial 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