MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX; ELECTRICAL STIMULATOR

Model Number NEXWAVE

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Device is shocking patient even with new pads and lead wires.

Manufacturer Narrative

Zynex: patient did not return ac adapter or lead wires.Unit turned on, passed final testing without any problems.No problem found.

• Brand Name: ZYNEX
• Type of Device: ELECTRICAL STIMULATOR
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO 80124
• Manufacturer Contact: 9990 park meadows drive; lone tree, CO 80124 ; 3037034906
• MDR Report Key: 4613398
• MDR Text Key: 18002712
• Report Number: 1723686-2015-00009
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NEXWAVE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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