Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2003, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2003, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 435135, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient was sick.They also had been having lead issues for about six months and started having nausea.They started taking zofran, which helped.It was noted that one lead was not working and had been reading crazy numbers.They started having the nausea and vomiting symptoms six months prior to the report.They had nausea 24/7 and in (b)(6) 2018 tried to change medication, but had violent episodes of vomiting.They stated they couldn¿t eat and wondered where the lead was placed.It was also reported that, in (b)(6) 2015, they ended up with post-operative pneumonia and ended up in a rehab center for this.No further complications were reported or anticipated.
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