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

Model Number	MODEL 4323
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pneumothorax was caused by a surgical tool called a ribbon retractor.This tool is not manufactured by inspire medical systems but since it caused the pneumothorax while being used during an inspire implant procedure, specifically in preparation for placement of the inspire model 4323 sensing lead we are filing this mdr.
Event or Problem Description
During tunnelling, prior to placement of the sensor lead, physician was using a malleable ribbon retractor which is not an inspire product.The retractor was placed into the intercostal space but planed slightly below the internal intercostal fibers.A slight noise was noted and some small bubbles were observed.Corrective measures were taken to manage what appeared to be a small pneumothorax.No lung collapse or volume change was noted and once it was determined the situation was stable the sensor was placed and the case completed as normal.The patient was observed and no further complications were noted.

• 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: 7945364
• Report Number: 3007666314-2018-00043
• Device Sequence Number: 10976943
• Product Code: MNQ
• UDI-Device Identifier: 10855728005496
• UDI-Public: 10855728005496
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: MODEL 4323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• 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: Required Intervention