SURGN CART 9735665 STEALTH S8 PREMIUM

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 2020-03-30 for SURGN CART 9735665 STEALTH S8 PREMIUM manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185609536] Other relevant device(s) are: product id: 9735737, software version: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185609537] Medtronic received information regarding a navigation system used during a cranial resection procedure. It was reported that they were inaccurate. They were having a lot of difficulty registering the patient and were attempting to use both touch and trace. They eventually got the metric to 0. 9, but were still inaccurate so aborted navigation with an hour delay. Troubleshooting determined that the side with the fiducials they were attempting to used appears to have a pad or something depressing the skin. No impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01100
MDR Report Key9897241
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2020-01-14
Date Added to Maude2020-03-30
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 NameSURGN CART 9735665 STEALTH S8 PREMIUM
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-30
Model Number9735665
Catalog Number9735665
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 2020-03-30

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