S7 STEALTHSTATION NAVIGATION SYSTEM 9733856

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for S7 STEALTHSTATION NAVIGATION SYSTEM 9733856 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185951796] A software analysis was initiated. Analysis found that the reported behavior was the intended functionality of the software. The software functioned as designed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185951797] Medtronic received information that, while outside of a procedure, the site was having issues with seeing surgeon profiles and procedures in the spine application software. It was reported that the site checked administrative settings and an error message was received. There was no patient present when this issue was identified. It was late reported that the imaging system tool card had been removed from the navigation system, which subsequently removed all procedures and profiles. To restore functionality, the tool card was re-added and tools were re-installed. Medtronic received information that the issue occurred during testing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01119
MDR Report Key9908000
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 NameS7 STEALTHSTATION NAVIGATION SYSTEM
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-31
Model Number9733856
Catalog Number9733856
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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