MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

Model Number	4340
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the time of the revision surgery, (b)(6) 2023, the lead was replaced to restore therapy.During the revision, the sensor tip was found to have separated from the lead body and to have migrated after separation.The physician determined that retrieving the sensor would expose the patient to greater risk and decided to leave the sensor behind in the patient.The revision surgery restored therapy and the issue is now resolved.
Event or Problem Description
Patient presented back to the physician with fractured sensing lead tip still in the body.Cardiothoracic surgeon brought the patient into the operating room and retrieved the severed sensing lead tip.

• Brand Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Common Device Name: INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer Contact: anthony meinz ; 5500 wayzata blvd.; suite 1600; golden valley, MN 55416 ; 7632057970
• MDR Report Key: 17992806
• Report Number: 3007666314-2023-00322
• Device Sequence Number: 7276954
• Product Code: MNQ
• UDI-Device Identifier: 10855728005892
• UDI-Public: 10855728005892
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4340
• Device Catalogue Number: 900-009-003
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown