The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are off-label use, incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerve outside the target nerve, interference from a non-curonix device, patient contraindicating conditions, and migration.However, the patient has contraindicating conditions, including anorexia.The stimulator is used to treat pain. the cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, or mental capacity as the patient is anorexic (user error - clinician).(b)(4) was initiated to investigate and remediate the noncompliance to company reporting procedures.
|