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	Fall (1848); Muscle Weakness/Atrophy (1967); Balance Problems (4401); Cough (4457)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted on (b)(6) 2025.On (b)(6) 2026, the patient experienced neurological symptoms including slurred speech, facial drooping, coughing with stimulation, generalized weakness, impaired mobility, and multiple falls requiring ems transport and hospital admission.Er evaluation reportedly included ct imaging and labs, with dehydration noted per surrogate.The patient self-discharged.No device malfunction was confirmed at the time of report.Device evaluation showed normal impedance and a normal incision site.The patient reported transient coughing with stimulation but was unsure if this was new.The patient agreed to turn the device off pending neurological evaluation.Mri documentation was provided.Follow-up with a neurologist is scheduled for on (b)(6) 2026.Device remains off.

• 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: 24772191
• Report Number: 3012309950-2026-00019
• Device Sequence Number: 18709142
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 04/02/2026
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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: 56 YR
• Patient Sex: Male