EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM 27666

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 2019-11-06 for EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM 27666 manufactured by Medtronic Neurosurgery.

MAUDE Entry Details

Report Number2021898-2019-00397
MDR Report Key9287225
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-06
Date of Report2019-11-06
Date of Event2019-10-25
Date Mfgr Received2019-10-25
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone7635263305
Manufacturer G1MEDTRONIC NEUROSURGERY
Manufacturer Street125 CREMONA DRIVE
Manufacturer CityGOLETA CA 93117
Manufacturer CountryUS
Manufacturer Postal Code93117
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
Generic NameDEVICE, MONITORING, INTRACRANIAL PRESSURE
Product CodeGWM
Date Received2019-11-06
Model Number27666
Catalog Number27666
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROSURGERY
Manufacturer Address125 CREMONA DRIVE GOLETA CA 93117 US 93117


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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