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

Model Number	1001
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient is not able to activate the ipg during at home therapy sessions using the magnet.Troubleshooting steps were performed.The patient is using a magnet that was not provided by mti to activate the device at home.Device will continue to be monitored by microtransponder and the therapist.If new information becomes available, this report will be updated.
Additional Manufacturer Narrative
Submission was delayed due to routine onsite fda inspection.

• Brand Name: MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
• Common Device Name: VIVISTIM® SYSTEM
• Manufacturer (Section D): MICROTRANSPONDER, INC.; 2802 flintrock trace; suite 226; ausitn TX 78737
• Manufacturer (Section G): MICROTRANSPONDER; 2802 flintrock trace; suite 226; austin TX 78737
• Manufacturer Contact: brent tarver ; 2802 flintrock trace; suite 226; austin, TX 78737 ; 8323305315
• MDR Report Key: 24646434
• Report Number: 3012309950-2026-00013
• Device Sequence Number: 21384402
• 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: 2026
• 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): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1001
• Device Lot Number: H5480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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
• Patient Age: 28 YR
• Patient Sex: Unknown