The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of increased pain are migration, improper simulation parameters, improper placement during surgery, patient contraindicating conditions, and interference from a non-stimwave device.The stimulator is used to treat pain. the cause of the reported issue is unknown. therefore, conclusion has been selected as no problem/fault found.Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.
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