MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented with suspected infection at the chest and neck incision.Prior to the surgery the patient¿s stimulation lead had eroded through the neck incision.Physician brought the patient into the operating room and determined there was no infection at the chest and neck incision.Physician flushed the exposed area and sutured the stimulation lead into place.This resolved the issue.
Event or Problem Description
Patient presented back to the physician with stimulation lead exposed.Physician brought the patient into the or, removed the stimulation lead, and left the remaining inspire components.

• Brand Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Common Device Name: INSPIRE MODEL 4063 STIMULATION 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: 15529421
• Report Number: 3007666314-2022-00011
• Device Sequence Number: 6078940
• Product Code: MNQ
• UDI-Device Identifier: 10855728005533
• UDI-Public: 10855728005533
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 4063
• Device Catalogue Number: 900-001-009
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown