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

Model Number	4063
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient is experiencing traction on the stimulation lead.
Event or Problem Description
Follow up report to 3007666314-2018-00053: patient reported the stimulation lead traction and pain.The issue was resolved by re-tunneling the stimulation lead and repositioning the ipg.Based on the above information, the root cause was concluded as sub-optimal implant location/depth/size.

• Brand Name: INSPIRE
• 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: 8184890
• Report Number: 3007666314-2018-00053
• Device Sequence Number: 1459918
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 07/15/2019
• 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