Patient was treated to relieve neurogenic claudication symptoms of lumbar spinal stenosis on (b)(6), by implantation of subject device.During the procedure, when advancing the access cannula, the first of two dilators "backed up" (dorsally) out of position.When the physician tapped the first dilator back into position, it advanced farther than desired.The physician immediately removed all instrumentation.Patient was under light sedation, and was able to speak to confirm his condition was "ok," and was able to feel and move lower extremities.The physician saw a small amount of fluid that he presumed might have been csf.The fluid stopped spontaneously, and the physician proceeded to complete the procedure.Patient was checked in recovery and reported a slight headache when walking.Patient was kept overnight for observation, and discharged the following morning.Per (b)(6) follow-up, patient reported no headache or other adverse sequelae, with >80% relief of lumbar stenosis symptoms.Per (b)(6) follow-up, patient reported no headache or other adverse sequelae, with >90% relief of lumbar stenosis symptoms.As of this date, patient continues to enjow relief from symptoms with no adverse sequelae.
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