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

Model Number	4063Si
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine follow-up appointment, the physician identified a device impedance issue.Imaging was obtained, which indicated a possible stimulation lead issue.Physician brought the patient to the operating room, and upon surgical exploration, the stimulation lead was found to be damaged.The physician noted twiddler syndrome, which posed a risk of patient injury.Physician explanted the existing stimulation lead, implanted a new lead, sutured, and closed.The revision surgery restored therapy, addressed the risk, and the issue is now resolved.

• 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: 50464499
• Report Number: 3007666314-2026-01508
• Device Sequence Number: 15927305
• Product Code: MNQ
• UDI-Device Identifier: 10855728005793
• UDI-Public: 10855728005793
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• 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: 08/12/2026
• 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