MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE SENSING LEAD

Model Number	4323
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that he has scheduled a revision surgery to reposition the sense lead for a patient that was implanted last fall.The patient is complaining of sharp pleural pain when he coughs.Additionally, patient noted that when the he rolls onto his side he experiences discomfort as well.
Event or Problem Description
Follow up to previous report (3007666314-2018-00018).Patient required revision surgery to address pain from sensor lead placement.Revision surgery to replace the lead in a different position was conducted on (b)(6) 2018.The surgery was completed with out any adverse events and appears to have addressed the issue.
Event or Problem Description
Follow up report: patient had a revision surgery to reposition sensing lead to address discomfort.During that revision surgery the insulation on the sense lead was breached, as confirmed by returned product analysis, requiring another procedure to replace it with a new sense lead.

• Brand Name: INSPIRE SENSING LEAD
• Common Device Name: SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 7691464
• Report Number: 3007666314-2018-00018
• Device Sequence Number: 11095158
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 900-002-005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 07/13/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention