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 Code	Convulsion/Seizure (4406)
Date of Event	05/27/2026
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, during a rehabilitation therapy session with stimulation, the patient reported generalized fatigue followed by a seizure.The seizure lasted approximately 1-2 minutes while the patient was seated.Following the event, the patient was transferred to the emergency department for evaluation and was discharged home the same day.The patient has a documented history of seizures prior to implantation.Follow-up information indicated the patient experienced an additional seizure at home on (b)(6) 2026.The patient's neurologist adjusted the patient's antiseizure medication and reportedly did not believe the seizures were related to vns therapy.The patient resumed daily magnet therapy, returned to part-time landscaping work, and no changes were made to the vivistim system.The device remains implanted.

• 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: 25644397
• Report Number: 3012309950-2026-00033
• Device Sequence Number: 15797513
• 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: 2025
• 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): 06/26/2026

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: 05/27/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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: 62 YR
• Patient Sex: Male