ASTRA XT DR MRI SURESCAN X2DR01

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 2019-11-30 for ASTRA XT DR MRI SURESCAN X2DR01 manufactured by Medtronic Europe Sarl.

MAUDE Entry Details

Report Number9614453-2019-04001
MDR Report Key9392238
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-30
Date of Report2019-12-02
Date of Event2019-11-23
Date Mfgr Received2019-11-29
Device Manufacturer Date2019-10-02
Date Added to Maude2019-11-30
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC EUROPE SARL
Manufacturer StreetROUTE DU MOLLIAU 31 CASE POSTALE
Manufacturer CityTOLOCHENAZ VAUD 1131
Manufacturer CountryCH
Manufacturer Postal Code1131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASTRA XT DR MRI SURESCAN
Generic NamePULSE GENERATOR, PERMANENT, IMPLANTABLE
Product CodeNVZ
Date Received2019-11-30
Model NumberX2DR01
Catalog NumberX2DR01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EUROPE SARL
Manufacturer AddressROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-11-30

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