The patient reported severe wound pain and overstimulation in the legs, and the device was reprogrammed.A revision procedure was performed.However, the date is unknown.The patient uses the system without any problems.Attempts to obtain additional information from the commercial team member were unsuccessful.No additional information provided.
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The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of unintended stimulation/overstimulation 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, and migration.Potential causes of wound pain are infection, migration, erosion, off-label use, and patient contraindicating conditions.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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