MAUDE Adverse Event Report: Mobia Medical, Inc. Vivistim® Paired VNS¿ System; Vivistim System

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Obstruction/Occlusion (2422)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the vivistim system on (b)(6) 2026.On (b)(6) 2026 the patient reported to the therapy development specialist ((b)(6) employee) at their first therapy protocol session that they had experienced stroke-like symptoms since coming out of the implant surgery, and were admitted to the hospital over the previous weekend from (b)(6) 2026.The implanted device remained off during this period before therapy initiation.Patient reported that ct imaging had been performed which identified a new and progressed occlusion.Mri imaging was reportedly planned but has not occurred to date to manufacturer's knowledge.As of date of report the patient is progressing through the therapy protocol and reported the deficits they experienced post-surgery had improved.No additional symptoms or interventions have been reported by patient or provider team since therapy protocol initiation on (b)(6) 2026.

• Brand Name: Vivistim® Paired VNS¿ System
• Common Device Name: Vivistim System
• Manufacturer (Section D): Mobia Medical, Inc.; 2802 flintrock trace; suite 226; austin TX 78737
• Manufacturer Contact: brent tarver ; 2802 flintrock trace; suite 226; austin, TX 78737
• MDR Report Key: 50216585
• Report Number: 3012309950-2026-00038
• Device Sequence Number: 6122929
• Product Code: QPY
• UDI-Device Identifier: 10810041430028
• UDI-Public: 10810041430028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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: Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Male