Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 29-jul-2021, udi#: (b)(4), product id: 4351-35, serial/lot #: (b)(4), ubd: 29-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a health care provider (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation. it was reported the impedance issues on electrode 2 >2 ,000 ohms.Caller programmed c+ and 3- but patient reported stimulation in abdomen.Reviewed possible flipped ins which can create intra-muscular stimulation.Also discussed that may be reason for lead impedance.Suggested x-ray for ins position and reducing amplitude to reduce,or alleviate stimulation sensation.Caller reported a year ago, impedance was 1,044 ohms.Patient has been having decreased symptoms in the past year, but then reported patient seems to have difficultly in general, and mentioned if the patient had an endoscopy they would probably see lead migration.No further complications were reported/anticipated at this time.
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