MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG

Model Number	3028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reports severe nerve pain radiating from her neck to the top of her head and migraine headaches.The physician reports that the patient's issue is not related to the implant, but that some aspect of the procedure triggered the problem as there was no history prior and symptoms started immediately post-op in the recovery room when she was coming out of anesthesia.Her physician has not activated her device.The physician referred the patient to a neurologist who prescribed multiple medications for symptom relief and an mri.Mri results were within normal limits.Neither the neurologist nor the ent feels this is related to the implant itself, but possibly positioning on the table injured the cervical nerve during the procedure.
Event or Problem Description
The physician concluded that the patient's injury was a cervical strain from positioning during surgery.The issue is now resolved and the patient was activated on (b)(6).

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: INSPIRE MODEL 3028 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8683671
• Report Number: 3007666314-2019-00037
• Device Sequence Number: 1968403
• Product Code: MNQ
• UDI-Device Identifier: 10855728005465
• UDI-Public: 10855728005465
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019
• Report Date (Section F): 01/01/2005

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: 3028
• Device Catalogue Number: 900-007-003
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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
• Date Report Sent to FDA: 01/01/2005