ENSITE? PRECISION? SYSTEM

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 2020-03-20 for ENSITE? PRECISION? SYSTEM manufactured by St. Jude Medical, Inc..

Event Text Entries

[184306629] The results, method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[184306630] During a procedure, when the non-abbott mapping catheter was inserted, a deviation of the radiological image was noted when compared to the navx image. On the x-ray image the mapping catheter was positioned by the left superior pulmonary vein, above the cs and his catheters, however on the navx image the mapping catheter appeared below the cs and his catheters. The navx patch placement and pin box assignment was verified, but the issue remained. The procedure was cancelled due to the inconsistent image. There was no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184149-2020-00036
MDR Report Key9860901
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-20
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, INC.
Manufacturer StreetONE ST. JUDE MEDICAL DRIVE
Manufacturer CityST. PAUL MN 55117
Manufacturer CountryUS
Manufacturer Postal Code55117
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENSITE? PRECISION? SYSTEM
Generic NameCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Product CodeDQK
Date Received2020-03-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.
Manufacturer AddressONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-20

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