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Model Number MSB_UNK_INST_METX |
Device Problem
Mechanics Altered (2984)
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Patient Problems
Intracranial Hemorrhage (1891); Spinal Cord Injury (2432)
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Event Date 05/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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Patient had excessive bleeding and dura mater was damaged.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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Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred during a med procedure in a patient diagnosed with lumbar disc herniation.It was reported that the image showed symptoms that could not be seen in 3d, and the operation was performed by switching it from 3d to 2d, but it did not switch.When the switch operation was performed, it came to notice that there was a lot of bleeding, and when it was checked, it was noticed that the dura mater was damaged.The screen was checked and it was concluded that the surgery could not be continued.It was opened, the dura mater was sutured, and the intervertebral disc was resected.Afterward, there was no information, particularly about the patient's health damage.The timing of the dura mater injury is not clear, so which equipment was used could not be identified. there was no other patient symptom reported.
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Search Alerts/Recalls
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