MICRA MC1VR01

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 2020-03-31 for MICRA MC1VR01 manufactured by Medtronic Ireland.

MAUDE Entry Details

Report Number9612164-2020-01417
MDR Report Key9902490
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-03-12
Date Added to Maude2020-03-31
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 IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICRA
Generic NameLEADLESS PACEMAKER
Product CodePNJ
Date Received2020-03-31
Model NumberMC1VR01
Catalog NumberMC1VR01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY IE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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