MAUDE Adverse Event Report: MOBIA MEDICAL, INC. VIVISTIM® PAIRED VNS¿ SYSTEM

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the vivistim® system on (b)(6) 2025.The patient completed the therapy protocol in (b)(6) 2026 without reporting voice-related complaints during treatment.In (b)(6) 2026, the treating speech-language pathologist (slp) reported that the patient was experiencing voice changes, including decreased vocal volume, with unilateral vocal cord involvement.The patient reported that the voice changes had not improved but had not worsened since the implant procedure.The patient participated in slp therapy, with mild improvement reported; however, no device programming changes or stimulation setting adjustments were made following completion of the therapy protocol.On june 2, 2026, the manufacturer became aware that the patient had informed the mobia medical therapy delivery specialist on (b)(6) 2026, that the patient had previously undergone a vocal cord injection performed by an otolaryngologist without resolution of symptoms as of (b)(6) 2026.The patient was advised to return every three months for repeat injections but elected not to continue due to the discomfort associated with the procedure.At the time of this report, the patient's voice changes persisted, and no additional medical or surgical intervention had been reported.The device remains implanted.

• Brand Name: VIVISTIM® PAIRED VNS¿ SYSTEM
• Common Device Name: VIVISTIM
• Manufacturer (Section D): MOBIA MEDICAL, INC.; 2802 flintrock trace; suite 226; austin TX 78737
• Manufacturer (Section G): MOBIA MEDICAL, 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: 25680970
• Report Number: 3012309950-2026-00034
• Device Sequence Number: 9595139
• Product Code: QPY
• UDI-Device Identifier: 10810041430028
• UDI-Public: 10810041430028
• 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: 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): 06/29/2026

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 Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: 55 YR
• Patient Sex: Male