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

Model Number	4323
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
No patient injury but the sensor lead produced abnormal waveforms.Patient continued to use therapy anyway for a while but eventually had a revision procedure to replace the sensor lead to address electrical leakage from the original lead.
Event or Problem Description
Follow up report to 3007666314-2018-00028: the "date received by manufacturer" in the initial report was 21-aug-2018.However following the submission of the initial report we have learned that a company representative was aware of the event prior to that time, specifically back on 13-dec-2018.The reason for this follow up report is to correct the "date received by manufacturer" to that of 13-dec-2018.
Event or Problem Description
Follow up report 002: previous follow up report correcting the awareness date indicated that the awareness date was dec 13, 2018 when in fact it was dec 13, 2017.The purpose of this 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: 7824466
• Report Number: 3007666314-2018-00028
• Device Sequence Number: 1573490
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 900-002-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 12/13/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/11/2018; 09/18/2018
• 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