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

Model Number	4340
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine examination, the physician observed a device sensing issue.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 found the distal sensor tip had separated from the lead body and had migrated after separation.The physician determined that retrieving the sensor would expose the patient to greater risk and decided to leave the sensor behind in the patient.Physician replaced the entire inspire system with no further issues.The revision surgery restored therapy and the issue is now resolved.
Event or Problem Description
The patient underwent a surgery on (b)(6) 2025, to retrieve a migrated sense lead body tip.The surgeon made 4 incisions and collapsed the patient's lung to gain access to the sensor tip and retrieve it.The surgeon placed a chest tube after the procedure was completed.

• Brand Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; 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: 20692190
• Report Number: 3007666314-2024-00547
• Device Sequence Number: 8700823
• Product Code: MNQ
• UDI-Device Identifier: 10855728005632
• UDI-Public: 10855728005632
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 4340
• Device Catalogue Number: 900-009-002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/29/2025
• 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