MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735665 |
Device Problem
Imprecision (1307)
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Patient Problem
Intracranial Hemorrhage (1891)
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Event Date 09/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The navigation system then passed the system checkout and was found to be fully functional.Concomitant medical products: other relevant device(s) are: product id: 2 9631, serial/lot #: (b)(4).Product id: 9735737, serial/lot #: (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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Medtronic received information regarding a navigation system and automated trajectory guidance unit being used during an electrode and probe placement procedure.It was noted that the procedure was a stereoelectroencephalography (seeg) procedure.It was reported that the patient experienced a hemorrhage along the trajectory of the plan.It was suspected that an inaccuracy caused the reported event.Additionally, it was reported that a medtronic imaging system was used for the patient registration.Additional information was received.It was reported that the physician has since updated their surgical technique to include applying pressure to the guide for the pitot indentation.It was noted that the occurrence, there was no clear indication of cause of the inaccuracy.It was noted that the updated workflow included registration via tracer registration and using 7-9 fiducials on the anatomy.
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Manufacturer Narrative
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H3) the software team investigated the reported issue and reviewed the logs and archive.Archive contains ct and mr images.Images were not as per stealth protocol.Images did not cover complete patient anatomy.No registration data was available and there were no plans in the archive.Requesting to use images as per stealth protocol.Apart from this we don't have any evidence to know the cause of inaccuracy.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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Manufacturer Narrative
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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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