It was noted during the field investigation that the patient is very thin, which likely contributed to the discomfort the patient was feeling from the implanted leads.The inadequate pain relief from the system is most likely related to one of the leads having migrated.It is unknown if the patient would have still been able to achieve adequate pain relief because the patient declined all troubleshooting and reprogramming that was offered and chose instead to explant the system.The explanted components were discarded by the medical facility, however there was no indication of any system or component failure.Lack of pain relief is likely due to the migrated lead, which is a known inherent risk of implantable neuromodulation systems.
|