MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4323 SENSING LEAD; PRESSURE SENSING LEAD

Model Number	MODEL 4323
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	12/21/2015
Type of Reportable Event	Malfunction
Event or Problem Description
The patient experienced episodes where the system's stimulation did not work properly, specifically it would feel weaker than normal.A check of the system showed that the patient's stimulation sensation threshold had nearly doubled.The system was explanted and a new sensing lead and implantable pulse generator were implanted.The explanted devices were decontaminated, and returned to the manufacturer where analysis indicated that the sensing lead had shifted position thru the moveable lead anchor.This reduced the size of the loop between the two anchors which is required for strain relief.The patient was not injured as a result of this incident, but if the event were to recur it is possible that it could lead to inappropriate stimulation therefore the manufacturer is filing this report.

• Brand Name: INSPIRE MODEL 4323 SENSING LEAD
• Common Device Name: PRESSURE SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; inspire medical systems inc.; 9700 63rd ave n, suite 200; maple grove MN 55369
• MDR Report Key: 5420030
• Report Number: 3007666314-2016-00001
• Device Sequence Number: 568066
• 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
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Report Date (Section B): 01/19/2016

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: MODEL 4323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR