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Model Number 9735665 |
Device Problem
Imprecision (1307)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Iatrogenic Source (2498)
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Event Date 11/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient information unavailable at time of filing.Other applicable components are: product id: 9735736, version: (b)(4).A medtronic representative went to the site to test the equipment.The system performed as intended and passed a system checkout.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 being used for a procedure.It was reported that a patient had a csf leak from a clinical case.It was noted that the doctor believed this was due to an alleged inaccuracy.The patient was affected.
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Manufacturer Narrative
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H3) the software analysis determined that no logs or exams were available.There was insufficient information to determine whether a software anomaly contributed to the reported behavior.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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Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure.Procedure.It was reported that a patient had a csf leak from a clinical case.It was noted that the doctor believed this was due to an alleged inaccuracy.The patient was affected.2019-dec-19 e3 (rep) new information received: surgical procedure is fess, delay to case was not provided and patient information was unavailable.2019-dec-26 additional information received: per (b)(6) (asm), the doctor was unable to clarify the surgical date or patient name.Unable to pull logs or archives without this information.Additional information will not be available.
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Manufacturer Narrative
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B5: additional information provided 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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