AZURE XT DR MRI SURESCAN W1DR01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-29 for AZURE XT DR MRI SURESCAN W1DR01 manufactured by Medtronic Puerto Rico Operations Co..

MAUDE Entry Details

Report Number3004209178-2019-22825
MDR Report Key9391850
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-31
Date Mfgr Received2019-10-31
Device Manufacturer Date2018-02-08
Date Added to Maude2019-11-29
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
Manufacturer CityJUNCOS PR 00777
Manufacturer CountryUS
Manufacturer Postal Code00777
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAZURE XT DR MRI SURESCAN
Generic NamePULSE GENERATOR, PERMANENT, IMPLANTABLE
Product CodeNVZ
Date Received2019-11-29
Model NumberW1DR01
Catalog NumberW1DR01
Device Expiration Date2019-07-28
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777


Patients

Patient NumberTreatmentOutcomeDate
150711. Required No Informationntervention 2019-11-29

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