MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD

Model Number	4323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient went to the hospital complaining of pain at sense lead site.Hospital suspected infection and surgeon opened the site, diagnosed a (b)(6) infection, and treated by removing fluids and packing the site.Revision surgery is scheduled.
Event or Problem Description
The surgeon removed the patient's sense lead in (b)(6) due to infection.The ipg and stimulation lead both also became infected and the surgeon removed both on (b)(6) 2020.

• Brand Name: INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 9641941
• Report Number: 3007666314-2020-00002
• Device Sequence Number: 2001674
• Product Code: MNQ
• UDI-Device Identifier: 10855728005526
• UDI-Public: 10855728005526
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 04/09/2020
• 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: 4323
• Device Catalogue Number: 900-002-010
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/10/2020
• 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