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

Model Number	4063
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device still implanted.
Event or Problem Description
Patient is experiencing tethering on his stimulation lead due to improper routing of the lead around the digastric tendon.A revision surgery will be required to address this issue.

• 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: 6567889
• Report Number: 3007666314-2017-00006
• Device Sequence Number: 1122818
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 00855728005017
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/15/2017
• 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