![]() After its dive into the data found 28% of MDRs cite “pain relief, inadequate” as a problem, FDA said the review “highlights the need for patients to undergo and demonstrate an adequate trial.” The next two most frequently cited Patient Problem Codes - “pain” and “therapeutic effects, unexpected” - also point to the possibility that some physicians may be implanting SCSs without performing trial periods.įDA also looked at the most frequently reported Device Problem Codes but appeared less concerned by the findings. Yet, FDA is concerned about compliance with the trial-phase requirement. Nevro, for example, provides pages of information for physicians on two different approaches to trial-phase implantation. The companies also provide information on how to carry out these trial periods. The labels on spinal cord stimulators are clear on the need for trial simulation periods: Materials from Abbott, Boston Scientific, Medtronic and Nevro state their devices are only for use in patients who received effective pain relief during trial stimulation. Device Events is also among the organizations that have highlighted dangers with spinal cord stimulators. The warning comes after a June report from Public Citizen called for FDA to tighten how it regulates the devices, including requiring original PMA submissions for all new models and reassessing whether any approved devices should be removed from the market. An agency review of 107,728 adverse event reports submitted in the last four years found 30,321 reports of unsatisfactory pain relief. Healthcare providers are supposed to trial the estimated 50,000 devices implanted each year from companies such as Abbott, Boston Scientific, Medtronic and Nevro to ensure they adequately relieve a patient’s pain. FDA on Thursday published a letter to healthcare providers outlining hundreds of reports of deaths and thousands of injuries and malfunctions with spinal cord stimulators, reminding physicians to follow product labels calling for a simulation in patients prior to permanently implanting the SCS devices.
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