MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG; INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

Model Number	4340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented at the er with her chest wound opened up.She will follow up with an office visit to the implanting md.
Event or Problem Description
Patient was seen by implanting physician.The sense incision was open, but it was not infected.The skin edges are 2-3 mm apart for approximately 2/3 of wound.Mupirocin and steri-strips were applied.Oral antibiotic were prescribed.The issue was resolved as of (b)(6) 2019 and the patient was activated.

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8946466
• Report Number: 3007666314-2019-00069
• Device Sequence Number: 16669051
• Product Code: MNQ
• UDI-Device Identifier: 10855728005458
• UDI-Public: 10855728005458
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020
• 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: 4340
• Device Catalogue Number: 900-009-001
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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
• Date Report Sent to FDA: 01/01/2005