CAPSUREFIX NOVUS LEAD MRI SURESCAN 5076-58

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 2019-11-29 for CAPSUREFIX NOVUS LEAD MRI SURESCAN 5076-58 manufactured by Medtronic Singapore Operations.

MAUDE Entry Details

Report Number3008973940-2019-03203
MDR Report Key9391638
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-23
Date Mfgr Received2019-11-05
Device Manufacturer Date2016-10-05
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
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 SINGAPORE OPERATIONS
Manufacturer Street49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE
Manufacturer CitySINGAPORE 486056
Manufacturer CountrySG
Manufacturer Postal Code486056
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPSUREFIX NOVUS LEAD MRI SURESCAN
Generic NameELECTRODE, PACEMAKER, PERMANENT
Product CodeDTB
Date Received2019-11-29
Model Number5076-58
Catalog Number5076-58
Device Expiration Date2018-09-14
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SINGAPORE OPERATIONS
Manufacturer Address49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE SINGAPORE 486056 SG 486056


Patients

Patient NumberTreatmentOutcomeDate
150761. Hospitalization; 2. Required No Informationntervention 2019-11-29

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