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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
No products have been returned to medtronic for analysis.Codes 4114, 3221, and 4315 are applicable.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information used during a sacroiliac and thoracolumbar procedure.It was reported that the site had stated that t he system had become intermittent.The site had rebooted the system and went back into navigation.However, when going back into navigate they were unable to see trajectory 1 view but were able to see all other views.The site used another navigation system to continue with the procedure.There was an unknown delay to the procedure.There was no impact to the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was provided.It was reported that the procedure was delayed by 15 minutes.The system was rebooted and this resolved the issue.
 
Manufacturer Narrative
The logs were reviewed, but they did not provide any information regarding the cause of  the reported complaint.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
H3: a medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The system passed the system checkout and was found to be fully functional.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
H3) software logs have been received by the manufacturer.However, analysis has not been completed at the time of filing.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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Brand Name
SURGN CART 9735665 STEALTH S8 PREMIUM
Type of Device
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key10007505
MDR Text Key189358551
Report Number1723170-2020-01319
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169722187
UDI-Public00643169722187
Combination Product (y/n)N
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Date Manufacturer Received07/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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