MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the er physician with the stimulation lead eroded through the neck incision.Er physician cleaned the area and covered the neck incision.Inspire physician brought the patient into the or the next day, opened the neck incision, and observed that a metal clip potentially left in the patient was sticking out instead of the stimulation lead.Physician removed the clip, flushed the neck area with an antibiotic solution, tucked the stimulation lead, and closed.
Event or Problem Description
Patient presented back to the physician with continued stimulation lead erosion at the neck incision site, despite a recent procedure intended to resolve the issue.Physician brought the patient into the operating room and removed the entire inspire system.Postoperatively, antibiotics were prescribed.

• 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: 19282174
• Report Number: 3007666314-2024-00218
• Device Sequence Number: 6335757
• Product Code: MNQ
• UDI-Device Identifier: 10855728005809
• UDI-Public: 10855728005809
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2025

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: 4063
• Device Catalogue Number: 900-001-011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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