STEALTHSTATION? S7 9733858

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for STEALTHSTATION? S7 9733858 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185951542] Other relevant device(s) are: product id: 9735585, version #: (b)(4). Site was not requesting service. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185951543] Medtronic received information regarding a navigation system being used for a cranial resection procedure. During the procedure, the system did not recognize the non-invasive tracker. The procedure was completed without the use of navigation. The issue resulted in a procedure delay of less than one hour. There was no impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01118
MDR Report Key9907756
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-29
Date Mfgr Received2020-03-29
Device Manufacturer Date2016-09-20
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
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? S7
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-31
Model Number9733858
Catalog Number9733858
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 2020-03-31

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