(b)(6) 2022, (b)(4)(con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that patient received a new ins battery implanted in 2020.Patient had reported that shortly after implantation, they were having pain under their ribs and said it was like starting from zero.Patient also stated they had pain on their stomach where they were getting nauseous, they wouldn't eat and symptoms had increased.Patient said they had monthly appointments with their gastroenterologist and they were also calling in between appointments because they were throwing up so many times during the day.Patient said they were throwing up and had "all the normal symptoms" and the symptoms did not improve.Patient said during an appointment, the managing doctor tried "moving the enterra", performed testing and found out that the device was turned off and said "that's why you're having these problems." patient said after the doctor changed the battery, their gastroenterologist said the device wasn't doing what it was supposed to be doing.Patient said the implanting doctor was able to turn on the implant and checked the battery and the battery was fine, but patient said "my body wouldn't go back to normal." patient said they were still experiencing pain on their left side and "it was the lead for the machine, it was hurting and couldn't find out what it was.".Patient said their implanting doctor checked and said the machine turns on and off by itself even though the device was disconnected from their body and other organs (due to stomach removal surgery- unrelated).Since they removed the patient's stomach, the device was obsolete.Patient stated the doctor said it would be best to have the device removed because "it wasn't doing anything there." patient believes the ins (battery and leads) was completely removed in july 2022, and "know it was after the 4th of july." at this time, explant information is not up to date.
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