The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the stimulator after the expiration date, not prepping the skin with antiseptic solution, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.The cause of the inflammation is unknown.However, the device was implanted off-label at the occipital nerve.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the inflammation is unknown.However, the device was implanted off-label at the occipital nerve (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.
|