On the questionnaire dated april 8, 2020, the clinical representative reported that the patient has received excellent pain relief from her spinal cord stimulator (fr8a-rcv-a0) implanted in the epidural space of the cervical region on the spine.On (b)(6) 2020, the patient had a return of the peripheral pain in the middle of her back, near the location of the fr8a-spr-b0 stimulator.The patient reported feeling something "pop" prior to the loss of therapy.This "pop" was believed to have been the anchoring stitch.The patient met with the implanting clinician for an x-ray.The x-ray confirmed stimulator (fr8a-spr-b0) caudal (towards the posterior) migration of approximately 15cm.This stimulator (fr8a-spr-b0) was implanted off-label, in the mid back outside of the epidural space as a peripheral nerve stimulator (pns).The implanting clinician has been granted tga special access for a tined stimq stimulators to perform a revision scheduled for (b)(6) 2020.The root cause of this migration is due to the spinal cord stimulator (fr8a-spr-b0) being implanted off-label outside of the epidural space of the spine, causing inability to appropriately anchor the stimulator to prevent migration.
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On (b)(6) 2020, the patient had a return of the peripheral pain in the middle of her back, near the location of the fr8a-spr-b0 stimulator.The patient reported feeling something "pop" prior to the loss of therapy.This "pop" was believed to have been the anchoring stitch.
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