MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE STIMULATION LEAD; NEUROSTIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented with a droopy right lower lip.Physician reported that patient's marginal mandibular nerve was damaged during implant, and the nerve may or may not improve during the healing process.Implant was still activated as planned.The physician did not think that it had any bearing on the functionality of the inspire device and wanted to move forward, as did the patient.No neurapraxia of the tongue was noted.
Event or Problem Description
This is a follow up report to mdr report # 3007666314-2017-00019, filed to update the report with the information that the injury completely resolved without intervention.

• Brand Name: INSPIRE STIMULATION LEAD
• Common Device Name: NEUROSTIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 6987670
• Report Number: 3007666314-2017-00019
• Device Sequence Number: 13484545
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 00855728005017
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: Physician
• Device Model Number: 4063
• Device Catalogue Number: 900-001-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 02/27/2018
• 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: Other; Disability