MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG

Model Number	3028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750); Unspecified Infection (1930)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to physician with sense lead incision dehiscence 2 months after implant.Physician believes the incision will heal without intervention and prescribed antibiotics to prevent infection.
Event or Problem Description
Patient presented to the physician with erosion at the sense lead incision site through which the suture anchor was visible.Physician surgically replaced the sense lead on (b)(6) 2021, resolving the issue.
Event or Problem Description
Patient presented back to the physician with wound dehiscence at the chest incision site.Physician brought the patient into the or, observed signs of infection at the ipg pocket, and remove the entire inspire system.

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: INSPIRE MODEL 3028 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer Contact: vang yang ; 5500 wayzata blvd.; suite 1600; golden valley, MN 55416 ; 7632057970
• MDR Report Key: 12042434
• Report Number: 3007666314-2021-00078
• Device Sequence Number: 11907460
• Product Code: MNQ
• UDI-Device Identifier: 10855728005762
• UDI-Public: 10855728005762
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

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: 3028
• Device Catalogue Number: 900-007-010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 07/26/2024
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/05/2021; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown