CRYOFLEX SURGICAL ABLATION PROBE 60SF2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-13 for CRYOFLEX SURGICAL ABLATION PROBE 60SF2 manufactured by Medtronic, Inc..

MAUDE Entry Details

Report Number3008592544-2019-00021
MDR Report Key8695050
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-06-13
Date of Report2019-09-12
Date of Event2019-05-23
Date Mfgr Received2019-08-22
Device Manufacturer Date2019-01-28
Date Added to Maude2019-06-13
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 STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street3800 ANNAPOLIS LANE
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRYOFLEX SURGICAL ABLATION PROBE
Generic NameSURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
Product CodeOCL
Date Received2019-06-13
Returned To Mfg2019-06-26
Model Number60SF2
Catalog Number60SF2
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-13

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