Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient needed an mri.A couple years ago, their doctor accidently turned their therapy off and they were very sick from it.Eventually a manufacturer representative came to check the implant and confirmed that therapy was turned off.They also mentioned one of their implants only lasted nine months because their pylorus would not open up (not alleged to be related to the device/therapy), thus the healthcare provider kept increasing stimulation that caused the longevity issue with the implant.The healthcare provider eventually used botox to help open the pylorus to allow the ins therapy to work.Additional information was received from a healthcare provider (hcp).The hcp reported that it was unknown whether the pylorus not opening up and subsequent use of botox was caused by or related to the device/therapy, and it was unknown whether or not the stimulator only lasting nine months was caused by normal battery depletion.The steps taken to try to resolve the therapy being off and the patient becoming sick from this were unknown.
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