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

Model Number	4063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on and was sent home the same day.The patient had gone off his blood thinning medications earlier that week, prior to surgery.His cardiologist instructed him to resume his blood thinning medication 2 days after the implant procedure.The next day he woke up and had developed a hematoma at the site of the stimulation lead.The patient was admitted to the hospital for the hematoma and the blood thinners were discontinued for 72 hrs and he was prescribed antibiotics.The hematoma looked much better the following morning and the patient was discharged.The patient was brought back in about 2 weeks later and was doing well.

• Brand Name: INSPIRE MODEL 4063 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: 7593885
• Report Number: 3007666314-2018-00013
• Device Sequence Number: 16597665
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 00855728005017
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: Physician
• Device Model Number: 4063
• Device Catalogue Number: 900-001-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/12/2018
• 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