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

Model Number 400400

Device Problem Mechanical Problem (1384)

Patient Problems Headache (1880); Pain (1994); Tachycardia (2095); Discomfort (2330)

Event Date 06/10/2017

Event Type  malfunction  

Event Description

The unit did not contract during nmes treatment.The unit was turned up to 100 ma with no effect; the unit was turned back down to 50 ma, the patient experienced what she described as sweeping pain up her body through her torso.A check connections error displayed prior to the event on channel 2.Pt used reusable self-adhesive original electrodes.Patient has experienced an elevated heart rate since the event.Patient noted the following: pain, noted tension in low to mid back and nausea at the end of session, but thigh and back pain had eased some.Since the event, the patient has reported an elevated heart rate beyond her usual value (which she states is usually in 70-72 bpm range and reported pcp confirmed) along with discomfort in her low and mid back.On (b)(6) 2017: the patient noted mild headache, felt her heart rate was elevated and vitals as follows: hr 104 bpm, bp 140/80 mmhg (1st reading) and then 130/70 mmhg (second reading), respiratory rate 12 cycles per minute.On (b)(6) 2017: resting heart rate 92 bpm, blood pressure 135/80 mm hg, no burn marks noted under electrode sites, but muscle tenderness and guarding in the lumbar, thoracic and cervical regions.On (b)(6) 2017: via phone conversation, the patient stated had follow-up appointment with pcp who ordered ekg which showed a change vs.The one performed prior to surgery and pcp deemed it "not significant" but was sending to cardiologist for further consult.On (b)(6) 2017: her heart rate was 86 bpm, and bp 128/82 mmhg.On (b)(6) 2017: she stated she went to emergency room (hr 108 bpm) and was fitted with holter monitor and would undergo a stress test.On (b)(6) 2017: pt was scheduled for a physical therapy evaluation to treat her spinal complaints but the patient canceled as her heart rate had climbed again and did not feel she could physically handle the demands of the evaluation.On (b)(6) 2017: via phone, patient reported continued cardiac issues with hr 120 bpm.On (b)(6) 2017: reported continues to wear holter monitor, had stress test and ct scan (results not known) and would be consulting with cardiologist.

• Brand Name: ZYNEX MEDICAL
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL INC.; 9555 maroon circle; englewood CO 80112
• Manufacturer (Section G): ZYNEX MEDICAL INC.; 9555 maroon circle; englewood CO 80112
• Manufacturer Contact: john mcinroy ; 9555 maroon circle; englewood, CO 80112 ; 8004956670
• MDR Report Key: 8297054
• MDR Text Key: 136875209
• Report Number: 1723686-2017-00002
• Device Sequence Number: 1
• Product Code: IPF
• 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: health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/23/2017,11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/23/2017
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR