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Model Number UNK-NV-MARATHON |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vasoconstriction (2126)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Monroe, e.J., chick, j.F., stacey, a.W., millard, n.E., geyer, j.R., ramoso, l.R., ghodke, b.V., <(>&<)>amp; hallam, d.K.(2020).Radiation dose reduction during intra-arterial chemotherapy for retinoblastoma: a retrospective analysis of 96 consecutive pediatric interventions using five distinct protocols.Pediatric radiology, 51(4), 649¿657.Https://doi.Org/10.1007/s00247-020-04892-x.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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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Event Description
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Monroe, e.J., chick, j.F., stacey, a.W., millard, n.E., geyer, j.R., ramoso, l.R., ghodke, b.V., <(>&<)>amp; hallam, d.K.(2020).Radiation dose reduction during intra-arterial chemotherapy for retinoblastoma: a retrospective analysis of 96 consecutive pediatric interventions using five distinct protocols.Pediatric radiology, 51(4), 649¿657.Https://doi.Org/10.1007/s00247-020-04892-x.Summary: intra-arterial chemotherapy (iac) represents a mainstay of retinoblastoma treatment in children.Patients with retinoblastoma are uniquely at risk for secondary malignancies and are sensitive to the ionizing effects of radiation identified events: 1.There were two (1.8%) major complications, two cases of ophthalmic artery vasospasm insufficiently responsive to vasodilators to allow infusion that required repeat treatment attempts.
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Search Alerts/Recalls
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