The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a damaged stimulator and the patient going through and mri have been ruled out as potential causes.However, the questionnaire shows the implant was not performed according to the ifu as the implanting clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, suture, and knot around the coil.Additionally, the patient has contraindicating conditions.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave 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 reported issue is due inadequate fixation as the implanting clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, suture, and knot around the coil (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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