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 Codes	Pain (1994); No Code Available (3191)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient described recent pain at the intercostal incision site.Ct ordered by implanting surgeon and possible breathing sensor migration into pleural space.Hardware/equipment is functioning as it should, patient ahi has been reduced from 47 to 1.4.
Event or Problem Description
The patient complained of pain in the intercostal incision site.The issue was resolved by repositioning the sensor lead at revision on (b)(6) 2019.No new product was implanted, the originally implanted breathing sensor was repositioned.

• 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: 8377772
• Report Number: 3007666314-2019-00021
• Device Sequence Number: 2925931
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019
• 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: 02/22/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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
• Date Report Sent to FDA: 01/01/2005