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 Codes	Numbness (2415); Limb Pain (4836)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 helpdesk and the esgngsupport 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 using ifc therapy for knee pain at 4-5 ma for 10 minutes.After receiving a "check connections" message, they changed the electrodes and increased the intensity to 43 ma but initially felt nothing.After a few minutes, they experienced numbness and sharp sensations in the foot that spread through the leg.The patient stopped the treatment immediately but continued to feel sharp sensations.

• 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: 24098920
• Report Number: 3000214920-2026-00003
• Device Sequence Number: 10243547
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: Lay User/Patient
• Device Model Number: 700400
• Device Lot Number: WOC2584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female