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Model Number UNK_NAV_SYS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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Event Date 05/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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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Manohar, n.Palan, a., deora, h., rajesh, b.J., balasubramanium, a., pradeep, k.Thermal injuries during intraoperative magnetic resonance imaging: mechanisms and prevention.Journal of neuroanaesthesiol critical care.2021.8 (66¿68) https://doi.Org/ 10.1055/s-0039-1685247 background: thermal injuries in a patient undergoing magnetic resonance imaging (mri) are rare; more so, when the patient in question is being operated upon.We attempt to elucidate the various factors that may predispose to such an unfortunate circumstance, through a series of four cases.Materials and methods: we conducted a retrospective review of our experience with intraoperative mri and found four cases of burns a ttributed to mri.Factors leading to possible injury were examined after other causes were ruled out.Results: collection of moisture between the leads and the patient¿s skin was the most common factor for the burns.There were no instances of closed loop formation or injury due to direct contact of cables to the skin.Conclusion: awareness of the causative factor can lead to prevention.Proper education of all concerned personnel involved in the conduction of the intraoperative mri is paramount to prevention of the same.Reported events: in case 3 there was a superficial burn postoperatively under the mri-compatible navigation tracker site or reference coil.
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 9734887, lot/serial #: unknown.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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