ENSITE? PRECISION? SURFACE ELECTRODE KIT EN0020-P

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 2019-11-15 for ENSITE? PRECISION? SURFACE ELECTRODE KIT EN0020-P manufactured by St. Jude Medical.

MAUDE Entry Details

Report Number3008452825-2019-00560
MDR Report Key9328200
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-15
Date of Report2019-11-23
Date of Event2019-03-05
Date Mfgr Received2019-11-18
Device Manufacturer Date2019-01-07
Date Added to Maude2019-11-15
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 (AFD)
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 NameENSITE? PRECISION? SURFACE ELECTRODE KIT
Generic NameCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Product CodeDQK
Date Received2019-11-15
Model NumberEN0020-P
Lot Number6798957
Device Expiration Date2019-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
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. Other 2019-11-15

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