S8 ENT STEALTHSTATION NAVIGATION SYSTEM 9735669

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 2020-03-30 for S8 ENT STEALTHSTATION NAVIGATION SYSTEM 9735669 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[188826171] Patient age not available from the site. Patient weight not available from the site. No parts have been received by the manufacturer for evaluation. Concomitant medical products: product id: 9735521, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188826172] Medtronic received information that, while in a temporal lobe tumor procedure, inflammation was observed around the midline of the lower jaw skin. It was reported that the issue occurred after about seven hours of the procedure. It was reported that there was no direct contact on the patient with the emitter. Additionally it was suspected that the emitter contributed to the inflammation. There was no reported delay to the procedure due to this issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01102
MDR Report Key9897540
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-25
Date Mfgr Received2020-03-26
Device Manufacturer Date2018-12-18
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 NameS8 ENT STEALTHSTATION NAVIGATION SYSTEM
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-30
Model Number9735669
Catalog Number9735669
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
101. Required No Informationntervention 2020-03-30

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