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	Electric Shock (2554)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned ipg was evaluated and no functional issues were identified during performance testing.Log files show initial programming to expected settings, which were unchanged leading up to explant date.Patient attended over 30 in-clinic therapy sessions and self-activated the device over 300 times between initial implant and explant procedures.No problems in the manufacture or use of the device have been identified.
Event or Problem Description
Patient was implanted on (b)(6) 2025 and began therapy protocol on (b)(6) 2026.The patient later subsequently reported experiencing chest shocking sensations while the device was not actively delivering stimulation.The implanting physician replaced the ipg on (b)(6) 2026, and the originally implanted lead was not replaced.Mobia medical personnel were not present during the procedure.Patient developed left-sided weakness approximately two weeks after the replacement procedure on (b)(6) 2026, was in hospital for two days, and discharged to out-patient rehab; ct imaging was reportedly inconclusive as to cause.The replacement ipg was turned on per physician clearance on (b)(6) 2026 to support at home use of the device.The explanted ipg was returned to mobia medical for evaluation.

• 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: 25310843
• Report Number: 3012309950-2026-00025
• Device Sequence Number: 9954695
• 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
• Device Explanted 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): 05/27/2026

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?: Yes
• Device Model Number: 1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Female