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

Model Number	1001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Loss of consciousness (2418); Electric Shock (2554)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on (b)(6) 2025.During the third occupational therapy session, which reportedly involved the combined use of external electrical stimulation at increased settings and the vivistim system, the patient experienced a loss of consciousness and was transported to the emergency department.The patient reported experiencing an intense electrical sensation originating in the thumb during the combined therapy.
Additional Manufacturer Narrative
This mdr is being submitted based on discussions with the fda during an onsite inspection.Device log files were obtained and reviewed for the period of 12/03/2025 through 03/20/2026, including the date of the reported event.Analysis of the ipg log files indicated that the patient participated in multiple in-clinic therapy sessions as well as at-home therapy sessions initiated using the magnet.The log data confirm that the ipg was programmed within the manufacturer's recommended settings and functioned as intended before, during, and after the event.Following the event, the patient has continued use of the vivistim system in both in-clinic and at-home settings without the use of external electrical stimulation and without recurrence of similar adverse events.At the time of the event, external electrodes were reportedly placed at the base of the thumb.No device malfunction was identified in the log files or otherwise reported to the company.Based on the available information, vns therapy is unlikely to have caused the loss of consciousness given the low stimulation settings and short stimulation duration.

• 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: 24811055
• Report Number: 3012309950-2026-00016
• Device Sequence Number: 9944486
• 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): 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: Health Professional
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male