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

Model Number	3000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The original implantation of the vivistim system occurred on (b)(6) 2024 (that surgeon is no longer at that hospital).On (b)(6) 2025, the patient underwent a revision of the neck incision at the lead insertion site by a different surgeon at a different hospital that has previously implanted the vivistim system with other patients.Microtransponder inc.(mti) includes four tie-downs in the lead packaging to secure the lead in place.It was reported, that one of the tie-downs appeared to be pushing against the surface of the skin, showing a small bump visible to the patient.The surgeon reopened the incision and removed the tie-down.Subsequent testing of both the lead and the implantable pulse generator (ipg) confirmed that they were functioning as intended.The tie down was disposed of at the hospital and will not be returned for evaluation.

• Brand Name: MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
• Common Device Name: VIVISTIM® SYSTEM
• Manufacturer (Section D): MICROTRANSPONDER, INC.; 2802 flintrock trace; suite 226; austin TX 78738
• Manufacturer (Section G): MICROTRANSPONDER, INC; 2802 flintrock trace; suite 226; austin TX 78738
• Manufacturer Contact: brent tarver ; 2802 flintrock trace; austin, TX 78738 ; 8323305315
• MDR Report Key: 23054224
• Report Number: 3012309950-2025-00004
• Device Sequence Number: 15596595
• Product Code: QPY
• UDI-Device Identifier: 10810041430080
• UDI-Public: 10810041430080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/12/2025

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
• Device Expiration Date: 09/13/2025
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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
• Patient Age: 51 YR
• Patient Sex: Female