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

Model Number	4323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician contacted inspire by text message stating that a patient had a minor pneumothorax on x-ray post op.No signs of problems intraoperatively and the patient was totally asymptomatic, but very clear small pneumo on post-op x-ray.No additional follow-up or intervention is expected from this.

• Brand Name: INSPIRE
• 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: 8249905
• Report Number: 3007666314-2019-00003
• Device Sequence Number: 1557815
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: 900-002-005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/15/2019
• 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