Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id: 97714, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: implantable, neurostimulator.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 977a260, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.
|
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that on group a they should feel stimulation in both legs.They stated they were trying to turn stimulation down on the right leg and turn stimulation up in the left leg, but they were only feeling stimulation in the right leg since (b)(6) 2018 (about a week ago).The patient tried group b and they were feeling stimulation a little bit in the left leg.The patient reported that their ¿leads were messed up¿ for about a year, since 2017.They stated in order for them to feel any type of relief with stimulation they had to ¿lay back¿.Their doctor told them they could do an x-ray to check their lead position, but the patient did not want to do that at the time.It was reported that while the patient was healing from their most recent implant they were in the process of moving and maybe did a little more than they should have.The patient was recommended to follow-up with their healthcare provider ( hcp) to discuss their symptoms and programming.It was indicated that when the patient used their programmer to communicate with their ins it showed that stimulation was on.No falls/traumas/emi activity were related to the event.An email was sent to a manufacturer representative (rep) to reach out to the doctor regarding the patient¿s issue.No further complications were reported/anticipated.
|