MAUDE Adverse Event Report: MOBIA MEDICAL, INC. VIVISTIM® PAIRED VNS¿ SYSTEM

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); Convulsion/Seizure (4406)
Date of Event	04/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the vivistim system on (b)(6) 2026.The patient has a pre-existing history of epilepsy and was taking anti-seizure medication prior to implantation.The patient's partner reported that the patient experienced episodes of lightheadedness toward the end of therapy sessions.On (b)(6) 2026, it was reported that the patient had experienced a seizure on (b)(6) 2026.It was reported the seizure was provoked by a viral illness and skin infection, both of which were treated at home.Based on the available information, the patient was not receiving device stimulation at the time of the seizure.The patient has continued therapy, and adjustments were made to the patient's seizure medications to address the reported symptoms.Review of the available information did not identify a device malfunction, and the reported event does not appear to be related to device performance or therapy.Although a causal relationship between the device and the reported event has not been established, this event is being submitted in an abundance of caution.

• Brand Name: VIVISTIM® PAIRED VNS¿ SYSTEM
• Common Device Name: VIVISTIM
• Manufacturer (Section D): MOBIA MEDICAL, INC.; 2802 flintrock trace; suite 226; austin TX 78737
• Manufacturer (Section G): MOBIA MEDICAL, INC; 2802 flintrock trace; suite 226; austin TX 78737
• Manufacturer Contact: brent tarver ; 2802 flintrock trace; suite 226; austin, TX 78737 ; 8323305315
• MDR Report Key: 25476884
• Report Number: 3012309950-2026-00028
• Device Sequence Number: 9165033
• 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): 06/10/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: Other
• Patient Age: 38 YR
• Patient Sex: Male