SJM TRIFECTA VALVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-07-18 for SJM TRIFECTA VALVE manufactured by St. Jude Medical, Costa Rica Ltda.

MAUDE Entry Details

Report Number3008452825-2019-00347
MDR Report Key8802698
Report SourceFOREIGN
Date Received2019-07-18
Date of Report2019-09-17
Date of Event2019-06-18
Date Mfgr Received2019-08-21
Date Added to Maude2019-07-18
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL, COSTA RICA LTDA
Manufacturer StreetPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL
Manufacturer CityALAJUELA, COSTA RICA 1897-4050
Manufacturer CountryCS
Manufacturer Postal Code1897-4050
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSJM TRIFECTA VALVE
Generic NameTRIFECTA STENTED TISSUE VALVE
Product CodeISP
Date Received2019-07-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, COSTA RICA LTDA
Manufacturer AddressPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-07-18

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