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	Infiltration into Tissue (1931)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During implant, the sensing lead penetrated the space between the internal intercostals and lung.The issue was recognized, the area was oversewn with two layers of suture.The area was flooded with saline, anesthesia performed valsalva without any bubbles being seen.The lead was then moved to a different rib space successfully.Post-op chest x-ray did not show pneumothorax.The patient was clinically asymptomatic and discharged per usual.

• 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: 8391027
• Report Number: 3007666314-2019-00023
• Device Sequence Number: 19190588
• Product Code: MNQ
• UDI-Device Identifier: 10855728005496
• UDI-Public: 10855728005496
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2019
• Report Date (Section F): 01/01/2005

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: 900-002-009
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/05/2019
• 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: Other; Required Intervention
• Date Report Sent to FDA: 01/01/2005