MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

Model Number	4340
Medical Device Problem Codes	Corroded (1131); Device Sensing Problem (2917); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a system check performed at a routine clinic visit, the physician observed a sensing issue.Physician brought the patient in for surgical intervention and observed corrosion at the ipg header sense lead pin connector port and at the sensing lead connector pin.Physician attempted to clean the corrosion, and the connector pin detached.Physician explanted the ipg and sensing lead and implanted a new ipg and sensing lead, and the incision was closed.Upon conclusion of root cause investigation and returned product analysis on 5 feb 2026, we found that the ipg grommet used to make contact with the lead connector was damaged with a pinhole tear in the slit.This allowed biologic material to ingress, resulting in device corrosion.This exposed the patient to corroded material.The device removal procedure addressed this risk and the issue is now resolved.

• Brand Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4340 RESPIRATORY SENSING 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: 24405464
• Report Number: 3007666314-2026-01045
• Device Sequence Number: 20888889
• Product Code: MNQ
• UDI-Device Identifier: 10855728005892
• UDI-Public: 10855728005892
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4340
• Device Catalogue Number: 900-009-003
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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