The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are migration, incorrect programming parameters, interference from a non-stimwave device, change in posture, stimulator electrical failure and patient contraindicating conditions. the stimulator is used to teat pain. the cause of the reported issue is unknown. therefore, conclusion has been selected as no problem/fault.Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.
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The patient reported pain in the groin and rectum.All company employees, including commercial team members, are trained to complaint reporting procedures.Select commercial team members failed to submit complaints in the appropriate internal complaint reporting system and instead documented complaints in alternate platforms.Upon identification of the unreported complaints, capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.Information regarding the patient, the product involved, nor patient outcome are available.
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