MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4063 STIMULATION LEAD

Model Number	MODEL 4063
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted and in use.
Event or Problem Description
Patient was not feeling any stimulation from the system.This was ultimately resolved by adjusting the device settings, but prior to this the patient underwent an extra surgical procedure to determine whether or not the stimulation lead implant needed to be revised.

• Brand Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Common Device Name: STIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 5710774
• Report Number: 3007666314-2016-00004
• Device Sequence Number: 16149304
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 0855728005017
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2016

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: Physician
• Device Model Number: MODEL 4063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2016
• Initial Report FDA Received Date: 06/09/2016
• 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