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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the vivistim system on (b)(6) 2024.On (b)(6) 2026, patient indicated to mobia personnel that the device had been explanted approximately one year ago.Follow-up with the implanting site indicated date of explant was on (b)(6) 2025.Patient denied any concerns that the device wasn't working and denied any discomfort when using the device.Patient did not complete the therapy protocol due to non-compliance and discharge by the clinic.No mobia personnel were present at the explant and no explanted device components returned for evaluation.
Additional Manufacturer Narrative
No further information is expected.Manufacturing records support the device was manufactured and tested to specification.Device was programmed to typical settings during therapy protocol, patient perception level was noted to be relatively high at 2.9ma and well above typical device setting of 0.8ma.

• 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
• MDR Report Key: 50384218
• Report Number: 3012309950-2026-00042
• Device Sequence Number: 5650834
• 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
• Device Explanted 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): 08/21/2026

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: 08/02/2024
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2022
• 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: 64 YR
• Patient Sex: Male