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

Model Number	MODEL 4323
Medical Device Problem Code	Device Abrasion From Instrument Or Another Object (1387)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented at dr.'s office with a golf ball size mass near the sensing lead incision.Looked a little swollen but the skin was normal.Dr.Said it was firm and mobile but not tender.Patient is being brought back for an additional dr visit and for a check to ensure the inspire system is functioning normally.
Event or Problem Description
Physician and patient decided to have the mass and the sensing lead removed.The removal went well.Upon inspection of the explanted lead we could see a "nick" near the fixed anchor that engineers hypothesized was the cause of the mass.All pathology reports were clear no sign of infection.Patient has since been seen by ent multiple times and hoping to get scheduled for reimplantation of sensing lead.

• Brand Name: MODEL 4323 INSPIRE SENSOR LEAD
• Common Device Name: LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 6068193
• Report Number: 3007666314-2016-00011
• Device Sequence Number: 18940912
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2016

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
• Device Catalogue Number: 900-002-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 02/22/2017
• 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: Other; Required Intervention