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

Model Number	4323
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced intercostal nerve pain due to the placement of the sense lead.Surgery was performed on (b)(6) 2020 to reposition the sense lead tip.This resolved the patient's issue.

• Brand Name: INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 10880689
• Report Number: 3007666314-2020-00061
• Device Sequence Number: 3315676
• Product Code: MNQ
• UDI-Device Identifier: 10855728005526
• UDI-Public: 10855728005526
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 4323
• Device Catalogue Number: 900-002-010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1