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

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Paresis (1998); Voice alteration (4906)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Following implantation surgery (b)(6) 2025, the patient developed hoarseness.Ent evaluation diagnosed left vocal cord paresis, dysphonia, recurrent laryngeal nerve palsy, and vagus nerve disorder.On (b)(6) 2025, device charge was reduced; voice remained raspy.On (b)(6) 2026, the patient underwent left vocal cord injection and was kept overnight due to post-anesthesia difficulty.A swallowing study performed on (b)(6) 2026 was reported as encouraging.Speech therapy is planned but had not started as of (b)(6) 2026.As of 01/23/2026, the patient reports no improvement in voice quality.The device remains implanted.No device malfunction has been identified.Investigation is ongoing.

• 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 78737
• Manufacturer (Section G): MICROTRANSPONDER, 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: 24328355
• Report Number: 3012309950-2026-00006
• Device Sequence Number: 13130491
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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: 79 YR
• Patient Sex: Female