CAPSURE EPICARDIAL LEAD 4965-25

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 2019-11-29 for CAPSURE EPICARDIAL LEAD 4965-25 manufactured by Medtronic, Inc..

MAUDE Entry Details

Report Number2182208-2019-02149
MDR Report Key9391773
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Device Manufacturer Date2009-04-14
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, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPSURE EPICARDIAL LEAD
Generic NameDRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Product CodeNVN
Date Received2019-11-29
Model Number4965-25
Catalog Number4965-25
Device Expiration Date2011-02-28
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

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

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