MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE; SIUMULATION LEAD

Model Number	4063
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient is experiencing traction on the stimulation lead.May require medical intervention to address.

• Brand Name: INSPIRE
• Common Device Name: SIUMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 7842800
• Report Number: 3007666314-2018-00033
• Device Sequence Number: 19328198
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/04/2018
• 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