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 Code	Convulsion/Seizure (4406)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being reported based on discussions with the fda during an onsite inspection.Device log files were obtained and reviewed for the period from 08/20/2024 to 10/28/2025, with the reported event occurring on 09/22/2025.Review of the log data indicates that the vivistim system functioned as intended before, during, and after the reported event.Per patient request, the stimulation amplitude was increased from 0.8 ma to 0.9 ma, within range of typical settings.The patient's medical history, log file data, clinical literature, and device updated stimulation settings were evaluated.Considering the established safety profile of vns, the low stimulation parameters, and type of stroke, the patient's stroke history, including known predictors of increased seizure risk within one year as described in peer-reviewed literature, along with confirmed device performance and clinical context, there is no objective evidence to suggestit is unlikely that the vivistim system caused or contributed to the reported event.
Event or Problem Description
The patient was implanted on (b)(6) 2024.It was reported that the patient experienced a seizure approximately 10 minutes after initiating a magnet session on (b)(6) 2025.A magnet session, which is a patient-initiated therapy period during which the vivistim system delivers vagus nerve stimulation (vns) paired with rehabilitation exercises.The patient was hospitalized overnight, during which an eeg and ct scan were performed.The patient was started on keppra and discharged the following day.The patient had used the vivistim system for approximately 13 months, with no reported issues.

• Brand Name: VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
• Common Device Name: VIVISTIM® SYSTEM
• 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: 24811085
• Report Number: 3012309950-2026-00017
• Device Sequence Number: 21219539
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Lay User/Patient
• Device Expiration Date: 05/02/2025
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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: 70 YR
• Patient Sex: Male