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

Model Number	4323
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient that was implanted (b)(6) 2018 complained of pain at the incision site of the sense lead.The surgeon took the patient into the or to revise the incision.They opened the existing incision and re-positioned the lead deeper.This resolved the issue.
Event or Problem Description
Patient continued to have pain following the previously reported surgery to reposition the sense lead.A 2nd surgery took place on (b)(6) 2020 to replace the sense lead.This resolved the issue.

• 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: 9752876
• Report Number: 3007666314-2020-00012
• Device Sequence Number: 2495200
• Product Code: MNQ
• UDI-Device Identifier: 10855728005526
• UDI-Public: 10855728005526
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020
• 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: 01/31/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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