The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when new pain occurred, changing the waa parameters intentionally or unintentionally, the patient having a non-curonix device implanted, not performing x-rays before and after the stimulation was experienced, device migration, and the patient experiencing new pain in a new area that is not targeted for therapy have been ruled out as potential causes.However, the patient has spinal stenosis and the implanting clinician believes the numbness was due to the lead placement.The stimulator is used to treat pain.The cause of the reported issue is due to patient being a poor candidate due to health, weight, age, or mental capacity as the patient has spinal stenosis (user error-clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.
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The patient reported numbness, immobility, discomfort, and severe swelling in their leg.An explant procedure was performed on (b)(6) 2023 which resolved the swelling.The patient is doing well, mobility has returned, and they are expected to be implanted with a new lead, however, a date has not been set.
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