MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE UPPER AIRWAY STIMULATION SYSTEM; IMPLANTABLE NEUROSTIMULATOR MODEL 3028

Model Number	MODEL 3028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Inspire 3028 ipg and leads were explanted at patients request for patient's possible allergic reaction to materials.

• Brand Name: INSPIRE UPPER AIRWAY STIMULATION SYSTEM
• Common Device Name: IMPLANTABLE NEUROSTIMULATOR MODEL 3028
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 7300510
• Report Number: 3007666314-2018-00003
• Device Sequence Number: 11071861
• Product Code: MNQ
• UDI-Device Identifier: 10855728005366
• UDI-Public: 10855728005366
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

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: Physician
• Device Model Number: MODEL 3028
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/27/2018
• 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