The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired stimulator, not prepping the skin with antiseptic solution, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes of the reported issue.The questionnaire shows the surgical site was not irrigated before closure and it is unknown whether the patient had any contraindicating conditions or if antibiotics were used pre-operatively.The patient engaged in minor physical activity following the implant procedure.Additionally, the patient has low body mass and the clinician believes the bump is the knot in the lead placed to set the receiver.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 bump and pain is likely due to the patient being a poor candidate due to health, weight, age, or mental capacity (user error -clinician; patient has low body mass).
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