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

Model Number	4323
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	03/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
After the implant surgery, the patient complained of right back pain which was worse lying flat or to the right side and worse with inspiration.Pain goes away when he holds his breathe.He is fine when he is upright.He denies any cough, fever, shortness of breath or issue with eating.Three weeks post surgery the patient received a ct of the chest which showed small to moderate right pleural effusion with adjacent limited infiltrate and atelectasis posterior right lower lobe.Patient's symptoms are stable but the effusion appeared to be similar one week later in ct scan.
Event or Problem Description
The patient's device was activated on (b)(6) 2019 at the physician's office.At this visit, the patient reported he was feeling better after having his lung drained.The patient was successfully activated without 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: 8444271
• Report Number: 3007666314-2019-00024
• Device Sequence Number: 16875535
• Product Code: MNQ
• UDI-Device Identifier: 10855728005403
• UDI-Public: 10855728005403
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 05/06/2019
• 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: 4323
• Device Catalogue Number: 900-002-008
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005