A woman who had a spinal cord stimulator implanted in 2020 is suing devicemaker Boston Scientific and the FDA over complications she experienced with the device.
Dena Lawler received the Spectra WaveWriter spinal cord stimulator to manage chronic lumbar postlaminectomy syndrome and refractory back pain, according to the lawsuit filed May 1 in the U.S. District court for Central California. Within a month of her initial surgery, she began experiencing new and worsening symptoms.
Evaluations revealed lead migration and malposition of the stimulation leads, and she had revision surgery three months after the first procedure, the lawsuit said. Then Ms. Lawler began having chest pain and was diagnosed with cardiac arrhythmia in early 2021.
The lawsuit alleged that substantial modifications to Ms. Lawler’s original implant affected its safety and efficacy and that Boston Scientific improperly used the premarket approval supplement pathway to implement updates instead of a new PMA review.
Ms. Lawler is seeking damages and a jury trial.
A spokesperson for the FDA said the agency doesn’t comment on ongoing litigation. Boston Scientific didn’t immediately respond to a May 5 request for comment.
