MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD

Model Number	4323
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine follow-up examination, physician observed a device sensing issue.The patient reported severe, painful shocking sensations deeper in the chest, preventing them from lying down.Imaging was performed, and the distal tip of the sensing lead was suspected of separating from the lead body.Physician brought the patient in for surgery and confirmed the distal sensor tip had separated from the lead body and migrated.The physician consulted with a cardiothoracic surgeon and deemed retrieval was a higher risk to the patient, so the sensor was abandoned.The physician removed the sense lead body and implanted a newer ipg model, which does not require a sensing lead, with no further issues.

• Brand Name: INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4323 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: 23596407
• Report Number: 3007666314-2025-00781
• Device Sequence Number: 10291253
• Product Code: MNQ
• UDI-Device Identifier: 10855728005496
• UDI-Public: 10855728005496
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4323
• Device Catalogue Number: 900-002-009
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/19/2025
• 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