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

Model Number	3000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a surgical pocket revision procedure because the lead connector boot was positioned in a manner that its shape could be seen below the skin.The patient had a cosmetic concern and the physician also felt that there may be a risk of erosion at that area.The pocket revision was completed and the final position of the lead connector boot was deeper and much less superficial than beforehand.There were no complications during the procedure.

• 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: 24284761
• Report Number: 3012309950-2026-00004
• Device Sequence Number: 13252475
• 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
• Device Implanted 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): 02/06/2026

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: 09/29/2026
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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: 45 YR
• Patient Sex: Female