MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3024 IPG

Model Number	3024
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to physician with pain and thinning of the skin at the ipg site.Surgeon replaced the ipg on (b)(6) 2020 to address patient''s pain as well as to address future mri needs.

• Brand Name: INSPIRE MODEL 3024 IPG
• Common Device Name: INSPIRE MODEL 3024 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 10563387
• Report Number: 3007666314-2020-00046
• Device Sequence Number: 2627846
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 3024
• Device Catalogue Number: 900-003-015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2020
• 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: Other; Required Intervention