The unintended stimulation / new pain was completed by quality with limited information. potential causes of new pain are implanting the device at an off-label location, migration, incorrect programming parameters, interference from a non-stimwave device, severe force applied to the implant 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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