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

Model Number	4323
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: x-rays taken during the explant indicate sensor was completely separated from lead body prior to extraction.The sensor end (distal tip) was not returned to inspire.Upon receipt at inspire, the returned portion of sense lead body was examined.Fluid ingress was observed within the lead body, and on the outer coil, for a length of 30 cm proximal to the separated end of the lead body.The cause of fracture could not be determined.Electrical functionality was not checked due to the amount of ingress, and the sensor having not been returned.Capa (b)(4) has been issued to investigate this failure mode further.
Event or Problem Description
Patient was implanted with inspire system (b)(6) 2018.Patient presented to physician on (b)(6) 2020 with pain at the sensor lead incision site after using a chainsaw and a shotgun.A revision surgery to replace the sense lead took place on (b)(6) 2020.During the revision surgery, the surgeon found that the sensor lead distal tip was detached the lead body.A thoracic surgeon was called into the revision procedure to find the sense lead tip.The thoracic surgeon opened the pleura in an attempt to find the tip and consequently the patient needed a chest tube.The sense lead tip could not be located.Patient was counseled that mri is contraindicated.

• 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: 10880509
• Report Number: 3007666314-2020-00058
• Device Sequence Number: 3315674
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2020
• 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