The patient reported a possible infection at the pocket site.Antibiotics were prescribed, the incision looks like its healing, there are no signs of infection at this time, and the patient continues to wear their device.
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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, not prescribing antibiotics pre-operatively, and the patient not attending the post-op visit have been ruled out as potential causes.However, the incision site was not irrigated with antibiotic solution before closure and multiple tunneling attempts were performed.Additionally, the patient broke open their scab while sleeping.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 infection is due to non-compliance to the ifu as the incision site was not irrigated with antibiotic solution before closure (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.
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