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

Model Number	4323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted (b)(6) 2018 and subsequently developed an infection at the sensing lead implant site.Patient has been put on antibiotic treatment and had the entire inspire system explanted on (b)(6) 2018.

• Brand Name: INSPIRE SENSING LEAD
• Common Device Name: PRESSURE SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 8014769
• Report Number: 3007666314-2018-00044
• Device Sequence Number: 1194810
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 900-002-005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/29/2018
• 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