MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE STIMULATION LEAD / MODEL 4063; NEUROSTIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient is experiencing traction on the stimulation lead.Physiican will be scheduling a revision surgery to address the issue.
Event or Problem Description
Follow up report: a revision surgery was completed to replace the stimulation lead with a new one.A significant venous bleed occurred with tunneling during the revision surgery and had to be managed with suturing.The surgeon elected to form a separate tunnel for final placement once the bleed was addressed.The final tunnel was formed without incident, and system validation at revision indicated excellent tongue motion and also resolved the issues of tethering at neck and uncomfortable stimulation.

• Brand Name: INSPIRE STIMULATION LEAD / MODEL 4063
• 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: 7787295
• Report Number: 3007666314-2018-00025
• Device Sequence Number: 1567885
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: Health Professional
• Device Model Number: 4063
• Device Catalogue Number: 900-001-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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