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

Model Number	4323
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a surgical procedure unrelated to inspire therapy the surgeon observed that the sensing lead, implanted 2.5 years earlier, was placed in the pleural space.There is no patient injury and the therapy is working well, but it appears that the patient experienced a self healing pneumothorax during the implant procedure.

• 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: 7945197
• Report Number: 3007666314-2018-00042
• Device Sequence Number: 857241
• Product Code: MNQ
• UDI-Device Identifier: 10855728005496
• UDI-Public: 10855728005496
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4323
• Device Catalogue Number: 900-002-009
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/08/2018
• 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: Other