Stimwave Fails to Include Alleged External Hardware Deficiencies as Complaints

FDA investigators found Stimwave Technologies’ complaint handling procedures for its implantable pain treatment devices were not up to par, during a Jan. 29-Feb. 15 inspection of the firm’s Pompano Beach, Fla. Facility.

The company makes wireless pain relief products called the Freedom spinal cord stimulator and the StimQ peripheral nerve stimulator that target nerves causing chronic pain. Faulty devices were returned to the manufacturer for not charging, not connecting or powering on and overheating, but many of the complaints were not entered into the firm’s complaint handling system.

Complaints of software-related performance problems did not go through the firm’s complaint handling procedure, which meant they were not evaluated to determine if the events should be reported to the FDA.