MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented at the doctor's office on (b)(6) with stimulation lead erosion at the incision site.The doctor reported that the patient is on biologic for psoriasis that makes the patient immunosuppressed.Removal of the implant is scheduled for (b)(6) 2019.
Event or Problem Description
The stimulation lead was removed 26 april 2019, which resolved the issue.

• Brand Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Common Device Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8444643
• Report Number: 3007666314-2019-00026
• Device Sequence Number: 2978544
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019
• Report Date (Section F): 01/01/2005

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 the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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
• Date Report Sent to FDA: 01/01/2005