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

Model Number	4323
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
No patient injury, but patient underwent a revision surgery to replace a sensing lead.The explanted lead was not returned.However on (b)(6) 2018 after reviewing the related information provided the likely root cause leading to the need for a revision surgery was electrical leakage due to a n insulation breach.
Event or Problem Description
Follow up report on 3007666314-2018-00027: initial report had a "date received by manufacturer" of 21-aug-2018.However since filing the initial report manufacturer has learned that a company representative was aware prior to that date.The actual "manufacturers awareness date" should be 11-sep-2017.The purpose of this follow up report is to make that correction.

• 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: 7824206
• Report Number: 3007666314-2018-00027
• Device Sequence Number: 1293582
• Product Code: MNQ
• UDI-Device Identifier: 10855728005403
• UDI-Public: 10855728005403
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4323
• Device Catalogue Number: 900-002-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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