MAUDE Adverse Event Report: ZYNEX MEDICAL, INC NEXWAVE

Model Number	700400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received therapy on their shoulder after surgery.It was stated by the surgeon that the patient's pulse was 20% below normal and both potassium and magnesium levels were low prior to treatment with the device.The treatment level at the time of the incident was at 4 ma.The doctor stated that the device possibly caused bradycardia and vasovagal due to carotid compression because of the placement of the electrodes.
Additional Manufacturer Narrative
This record was discovered as part of a historical review of data.Once it was discovered that it was reportable, we initiated the mdr.The file was compiled in the esubmitter program but was never submitted via esg until it was discovered as part of 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 cesubhelpdesk and the esgngsupport support email links on (b)(6) 2025, the first response we received for support was on (b)(6) 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 (b)(6)2025.On (b)(6) 2025, i received an acknowledgement from the esubmitter help desk that they discovered an issue with the program and would respond when resolved.On (b)(6) 2025, we received a solution and directions for fixing the software bug, which resolved the issue.

• Brand Name: NEXWAVE
• Common Device Name: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC; 14800 grasslands dr.; englewood
• Manufacturer (Section G): ZYNEX MEDICAL, INC.; 14800 grasslands dr; englewood CO 80112
• Manufacturer Contact: justin harrington ; 14800 grasslands dr; englewood, CO 80112 ; 7204652294
• MDR Report Key: 24021779
• Report Number: 3000214920-2026-00001
• Device Sequence Number: 18425956
• 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): 01/08/2026

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: 700400
• Device Lot Number: 1331379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 73 YR
• Patient Sex: Male