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

Model Number	4063
Medical Device Problem Codes	No Apparent Adverse Event (3189); Missing Value Reason (3192)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician hit a branch of the anterior jugular vein while using the codman catheter passer to tunnel the stimulation lead down into the ipg pocket.He was unable to control the bleeding through the existing incisions and had to make an extra 1 cm incision to access the vein and stop the bleeding.Postoperatively the patient had a nosebleed in the pacu from intubation, was hypertensive and the marginal mandibular branch of the facial nerve was weak, likely from retraction.No hematoma.She was fine with extra 1 cm incision.Later the next morning: no nosebleed overnight, blood pressure better, no hematoma, in good spirits, right lower lip weakness will be followed.
Event or Problem Description
Follow up report: physician confirmed that all issues have resolved including the facial/right lower lip weakness.

• 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: 7476547
• Report Number: 3007666314-2018-00006
• Device Sequence Number: 1768858
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 00855728005017
• Combination Product (Y/N): N
• 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: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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