MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
|
Back to Search Results |
|
Model Number 9735602 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the system.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system was having issues connecting to the emitter.There was no patient present when this issue was identified.
|
|
Manufacturer Narrative
|
H3, h6: the software investigation was unable to determine probable cause without further information since the behavior could not be replicated.Evaluation codes that apply to this testing: 10, 213, 4315.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.
|
|
Manufacturer Narrative
|
Information references the main component of the system.Other relevant device(s) are: product id: 9735638, version: 1.0.Medtronic representative stated that issue was most likely caused by the software.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.
|
|
Event Description
|
Additional information received stated that the site was able to resolve the issue by rebooting the computer.
|
|
Search Alerts/Recalls
|
|
|