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

Model Number	3024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Capa remediation.
Event or Problem Description
The patient developed very mild erythema over the ipg site noted on the post-op visit and was started on an antibiotic.It completely resolved, uneventfully on follow up visit.Date of event unknown.

• 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: 8772068
• Report Number: 3007666314-2019-00053
• Device Sequence Number: 1708607
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019
• 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: 3024
• Device Catalogue Number: 900-003-015
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2019
• Initial Report FDA Received Date: 07/09/2019
• 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: Other; Required Intervention
• Date Report Sent to FDA: 01/01/2005