Model Number 37800 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Nausea (1970); Pain (1994); Vomiting (2144)
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Event Date 11/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 05-sep-2020, udi#: (b)(4).Product id: 4351-35, serial/lot #: (b)(4), ubd: 14-jun-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.It was reported that the patient had an increase in pain, nausea, and vomiting due to lead erosion.The healthcare provider (hcp) suspected lead erosion and scheduled the patient for an egd, possible lead revision surgery.A ct scan done raised suspicion of lead erosion and then confirmed via egd.The hcp proceeded with removal and replacement of all components. a laparotomy was performed to remove and replace of all components.The leads and gastric neurostimulator were replaced on (b)(6) 2020.No further complications were reported.
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Manufacturer Narrative
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H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis determined that the implantable neurostimulator (ins) was functional.Continuation of d10: product id: 4351-35, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead; product id: 4351-35, serial# (b)(6), implanted: (b)(6) 2018, product type: lead.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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Search Alerts/Recalls
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