ZYNEX MEDICAL 400400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for ZYNEX MEDICAL 400400 manufactured by Zynex Medical Inc..

Event Text Entries

[136875209] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1723686-2017-00002
• MDR Report Key: 8297054
• Date Received: 2019-02-01
• Date of Report: 2018-11-19
• Date of Event: 2017-06-10
• Report Date: 2017-06-23
• Date Reported to Mfgr: 2017-06-23
• Date Mfgr Received: 2017-06-23
• Device Manufacturer Date: 2012-03-19
• Date Added to Maude: 2019-02-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JOHN MCINROY
• Manufacturer Street: 9555 MAROON CIRCLE
• Manufacturer City: ENGLEWOOD CO 80112
• Manufacturer Country: US
• Manufacturer Postal: 80112
• Manufacturer Phone: 8004956670
• Manufacturer G1: ZYNEX MEDICAL INC.
• Manufacturer Street: 9555 MAROON CIRCLE
• Manufacturer City: ENGLEWOOD CO 80112
• Manufacturer Country: US
• Manufacturer Postal Code: 80112
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ZYNEX MEDICAL
• Generic Name: NEXWAVE
• Product Code: IPF
• Date Received: 2019-02-01
• Returned To Mfg: 2017-06-30
• Model Number: 400400
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 YR
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZYNEX MEDICAL INC.
• Manufacturer Address: 9555 MAROON CIRCLE ENGLEWOOD CO 80112 US 80112

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-02-01