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

Model Number	4063
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon inadvertently cut the digastric tendon during the stimulation lead implantation.The tendon was surgically repaired during the implant procedure.Implant proceeded without further incident or complication.

• Brand Name: INSPIRE
• Common Device Name: STIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; mplae grove MN 55369
• MDR Report Key: 8060053
• Report Number: 3007666314-2018-00046
• Device Sequence Number: 13949902
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/12/2018
• 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