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

Model Number	3000
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the initial implantation procedure for the vivistim system, the surgeon identified anatomical limitations involving the patient's vagus nerve that prevented safe placement of the helical lead.The vagus nerve was reported to be too small for the 2 mm helical lead and contained multiple branches that interfered with lead placement.The implanting physician consulted a colleague intraoperatively to confirm identification of the vagus nerve, and the colleague concurred with the assessment.Due to the patient's anatomy, the implant procedure was aborted and the device was not implanted.No device malfunction was identified.No injury to the patient was reported and the patient recovered from the procedure without the need for additional medical or surgical intervention related to the event.The event is considered related to patient anatomy rather than device performance.
Additional Manufacturer Narrative
Devices will not be returned for evaluation.

• 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: 25186469
• Report Number: 3012309950-2026-00023
• Device Sequence Number: 10652787
• Product Code: QPY
• UDI-Device Identifier: 10810041430066
• UDI-Public: 10810041430066
• 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
• 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): 05/15/2026

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: 3000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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: 56 YR
• Patient Sex: Unknown