MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4323 SENSOR LEAD

Model Number	MODEL 4323
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evidence of device malfunction but user error may have caused a pneumothorax.While it appeared to resolve during the initial implant procedure, the procedure was prolonged as a result of this issue.Device remains implanted and in use.
Event or Problem Description
Surgeon completed an inspire system implant for a patient at (b)(6) medical center on (b)(6) 2017.During preparation of the sensor lead location he felt the ribbon retractor penetrated near the pleura potentially through the external and internal intercostal muscles.He halted preparation of the sensor space and took action to asses for potential pneumothorax.With assistance from anesthesia he irrigated the incision site while the lungs were expanded.A small amount of air bubbles was noted initially but resolved upon further testing.Lung volume remained stable during testing and afterward during successful placement of the sensor and completion of the implant procedure.The patient remained stable for the remainder of the case and during time in post op.The patient was kept overnight for observation which was pre-planned prior to the case and remained asymptomatic upon discharge.Observation of surgeon and inspire personnel was that the ribbon retractor used for the case was more rigid than the recommended ruggles and may have contributed to the deeper plane.A ruggles retractor was used during an earlier case without incident.

• Brand Name: INSPIRE MODEL 4323 SENSOR LEAD
• Common Device Name: SENSOR LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 ^3rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 6440179
• Report Number: 3007666314-2017-00002
• Device Sequence Number: 13637305
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/28/2017

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: Physician
• Device Model Number: MODEL 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: 02/27/2017
• Initial Report FDA Received Date: 03/28/2017
• 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: Hospitalization