The surgical issue questionnaire was completed by quality with limited information. potential causes of the reported issue are patient non-compliance (touching or picking at the wound), implanting non-sterile device, surgical (not irrigating the site with antibiotic solution before closure, not using antibiotics pre-operatively, not implanting in sterile field, not prepping the skin with antiseptic solution, using inappropriate tools, multiple tunneling attempts), patient contraindicating conditions, migration, improper stimulator placement during surgery, and improper programming parameters.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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