The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review changing the parameters of the transmitter has been ruled out as a potential cause.Per freedom scs instructions for use (05-20400), "a patient with the scs freedom-8a neurostimulator (electrode arrays with connected receiver) can be safety scanned in an mr system meeting the following conditions: static magnetic field of 1.5-tesla or 3-tesla." the cause of the reported issue is unknown.The stimulator is used to treat pain.The cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
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