STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM 9734060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM 9734060 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[186751692] No service had been requested from the site. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186751693] Medtronic received information regarding a navigation system being used for an spine procedure. During the procedure, the instrument tool cards could not be added into the software after installing spine tools. The manufacturer representative confirmed the instrument tools did not show in the "instruments not at this site" section. Reinstall of the tools database did not resolve the issue. The reported issue resulted in approximately a 45 minute procedure delay. The procedure was completed with the use of another navigation system. Further actions included requesting uninstall/reinstall of the spine software. To date, this had not been completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01097
MDR Report Key9892334
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-27
Model Number9734060
Catalog Number9734060
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.