STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE 27819

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 2020-03-30 for STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE 27819 manufactured by Medtronic Neurosurgery.

MAUDE Entry Details

Report Number2021898-2020-00110
MDR Report Key9898156
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-08-12
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 ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
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 NameSTRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
Generic NameSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Product CodeJXG
Date Received2020-03-30
Model Number27819
Catalog Number27819
Lot NumberE70404
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
101. Hospitalization; 2. Required No Informationntervention 2020-03-30

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