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

Model Number	4063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor called regarding a patient who may have an infected incision for the stimulation lead implant.He cultured the site on (b)(6) 2018 and is awaiting pathology report.In the meantime he has begun a course of antibiotics and upon confirmation of pathology will determine if explant is necessary.
Event or Problem Description
Physician initially reported that patient may have an infected incision at the neck site.However subsequent patient follow up indicated that there was no infection, rather it was determined to be a superficial issue caused by a suture and the patient is doing well.Based on the above information, the root cause was concluded as surgery healing related.

• Brand Name: INSPIRE STIMULATION LEAD / MODEL 4063
• 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: 7787162
• Report Number: 3007666314-2018-00024
• Device Sequence Number: 11275087
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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
• Device Catalogue Number: 900-001-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement 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