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	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to the physician with the stimulation lead coming out of their neck.Physician brought the patient into the or and placed the stimulation lead back into place.
Event or Problem Description
Patient presented with erosion and exposure of the stimulation lead.Physician brought the patient into the operating room, dissected, re-positioned the stimulation lead, and placed the lead deeper.
Event or Problem Description
Patient presented back to the physician with the stimulation lead eroded through the skin.Physician brought the patient into the or, placed the lead under the digastric tendon, sutured the lead down, and closed.
Event or Problem Description
Patient presented back to the physician with the stimulation lead eroded through the skin.Physician brought the patient into the or, opened the incisions, and suspected a manipulation of the lead.Physician removed the entire inspire system.

• 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: vang yang ; 5500 wayzata blvd.; suite 1600; golden valley, MN 55416 ; 7632057970
• MDR Report Key: 14947193
• Report Number: 3007666314-2021-00322
• Device Sequence Number: 4995343
• Product Code: MNQ
• UDI-Device Identifier: 10855728005533
• UDI-Public: 10855728005533
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2024

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; Not provided; Not provided
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 11/28/2022; 09/11/2023; 05/08/2024
• 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