Product id 435135 lot# serial# (b)(4).Implanted: (b)(6) 2011 explanted.Product type lead product id 435135 lot# serial# (b)(4).Implanted: (b)(6) 2011, explanted.Product type lead.Other relevant device(s) are: product id: 435135, serial/lot #:(b)(4), ubd: 13-jul-2013, udi (b)(4), product id: 435135, serial/lot #: (b)(4), ubd: 05-oct-2013, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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2022-jun-03 (b)(4) (con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that, nothing's been working right, they thought maybe pt had a mechanical bowel obstruction.Pt said they are feeling different things with their gastric pacemaker.Patient thinks the (leads) got twisted on the left side of their colon and the right side of the pacemaker (leads) got twisted they can't see the lead they are feeling different things with their gastric pacemaker. everything is fine but pt thinks the left side of their colon and the right side of pacemaker (leads) got twisted they can't see the lead, all they can see is stool (in the ct).Pt said: one girl could see the pacemaker, but pt feels like it shifted.Pt said they think when they threw up so much the leads came out and are obstructing around the colon.Pt said since (b)(6) 2021, they have been getting shockedgetting shocked, getting pain on the right side like a wire is trying to come through their skin.The patient was redirected to their healthcare provider to further address the issue.Pt said they have been doing all these tests with their colorectal doctor.
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