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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Voice alteration (4906)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was submitted late due to delayed identification of reportable complaint information.Capa 22 was raised in mti's qms.The capa investigation identified gaps in complaint reporting training, resulting in untimely documentation and mdr evaluation.Upon recognition, the mdr was promptly submitted and corrective actions were implemented.An audit has occurred to ensure there are no additional mdrs and effective training was implemented.
Event or Problem Description
On (b)(6) 2025, the patient was implanted with the vivistim system at (b)(6).Postoperatively, the patient developed unilateral vocal cord paralysis, resulting in speech difficulties.The patient was evaluated by ent and received steroid injections with limited improvement.A subsequent fat transfer procedure to the vocal cords was performed, resulting in partial improvement.The patient is currently participating in speech therapy.No device malfunction has been reported.

• 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: 24406716
• Report Number: 3012309950-2026-00011
• Device Sequence Number: 8224233
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 08/16/2025
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• 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: 71 YR
• Patient Sex: Male