MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. NEXWAVE

Model Number	800400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We initially filed this mdr through esubmitter but failed to complete the submission via esg.This was discovered during an audit.At that point, we discovered the esg portal wasn't properly set up for zynex medical, inc.While updating esubmitter, we learned that the esubmitter program needed to be updated.While updating the esubmitter program, we discovered a bug in the program that wouldn't allow the completion of the submission.A ticket was initiated and submitted to both cesub help desk and the esgng support email links on november 3, 2025, november 10, 2025, november 18, 2025, november 19, 2025, the first response we received for support was on 12/3/2025, which directed us to uninstall/reinstall the software, which we did twice, with no resolution.We then attempted to install the software on a completely different computer, which failed to resolve the issue as well.I then submitted additional help desk tickets to the esubmitter, cdrhesub, and emdr support links on 12/9/2025.On 12/11/2025, i received an acknowledgement from the esubmitter help desk that they discovered an issue with the program and would respond when resolved.On 12/29/2025, we received a solution and directions for fixing the software bug, which resolved the issue.
Event or Problem Description
The patient was at a clinic and the electrodes were placed around his knee cap to show the patient how to use the device and when the device was turned to 3ma on ifc the patient lost conciousness for approximately one minute.The clinic immediately removed the device and notified the territory manager.

• Brand Name: NEXWAVE
• Common Device Name: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; 14800 grasslands dr; englewood co CO 80112
• Manufacturer (Section G): ZYNEX MEDICAL, INC.; 14800 grasslands dr; englewood co CO 80112
• Manufacturer Contact: justin harrington ; 14800 grasslands dr; englewood, CO 80112 ; 7204652294
• MDR Report Key: 24085715
• Report Number: 3000214920-2026-00002
• Device Sequence Number: 9701224
• Product Code: LIH
• UDI-Device Identifier: 00852670007007
• UDI-Public: 00852670007007
• Combination Product (Y/N): N
• PMA/510(K) Number: K111279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: 800400
• Device Lot Number: 1317777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (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 Sex: Male