The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are incorrect programming parameters, off label-use, change in posture or proximity of electrode to target nerve resulting in stimulation of nerve outside the target nerve, interference from a non-stimwave device, patient contraindicating conditions, and migration.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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