MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX ; NEXWAVE

Device Problems Charred (1086); Temperature Problem (3022)

Patient Problems Headache (1880); Pain (1994)

Event Date 05/04/2015

Event Type  malfunction  

Manufacturer Narrative

Unit evaluated on (b)(6) 2015.Patient returned unit w/lead wires and ac adapter, but no battery.Leads and ac adapter tested good.Device powered on and passed all final testing.Could not duplicate patient complaint.

Event Description

Patient treating neck.Treated w/unit and woke up next day w/headache and neck pain.Stating unit injured her.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO 80124
• Manufacturer Contact: 9900 park meadows dr.; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 5168121
• MDR Text Key: 28944573
• Report Number: 1723686-2015-00017
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other