Zynex Receives Warning Letter from FDA
The U.S. Food and Drug Administration has issued a warning letter to Zynex Medical claiming that the company failed to adequately document and report adverse events linked to its NexWave chronic pain device and IF8000 electrical stimulator.
Zynex Fails to Notify FDA of Recall
According to MassDevice, Zynex failed to report adverse events to the FDA and even initiated a recall for 2,978 IF8000 electrical stimulators without notifying the federal reculators of any possible defects.
Further, the letter alleges that Zynex failed to “establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit” and did not document any product complaint reports for complaints received between December 13, 2012 and December 31, 2013.
Companies are required to notify the FDA of any adverse event reports within 30 days of receiving the reports and must submit written notification to the FDA within 10 days of initiating a recall.
Users of the IF8000 electrical stimulator and the NexWave chronic pain device reported adverse events including overheating, device failure, and burns.
Other Observations Cited in the FDA Letter
Other observations made by inspectors during an inspection of Zynex’s Lone Tree, Colorado plant include:
- Failure to establish adequate procedures for design inputs
- Failure to establish procedures for design verification
- Failure to establish a device master record
- Failure to maintain device history records with all the information required
- Failure to establish procedures for corrective and preventive actions
- Failure to establish procedures for internal audits