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	Medical device site infection (4845)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on (b)(6) 2026.On (b)(6) 2026, a rehabilitation facility reported a suspected infection at the ipg pocket site after the patient cancelled a scheduled appointment.The patient was subsequently evaluated on (b)(6) 2026 and remained admitted over the weekend for observation and treatment.Implanting physician was notified and initiated intravenous antibiotics.Clinical assessment indicated that the infection was superficial.The patient was discharged on (b)(6) 2026 with a prescription for oral antibiotics.The patient is being followed by nurse navigation and internal teams for ongoing monitoring.

• 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: 25061185
• Report Number: 3012309950-2026-00022
• Device Sequence Number: 18480221
• 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): 05/01/2026

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 Expiration Date: 03/09/2026
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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: 45 YR
• Patient Sex: Female