CD2257-40 FORTIFY ASSURA DR ICD_IDE_US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-29 for CD2257-40 FORTIFY ASSURA DR ICD_IDE_US manufactured by St. Jude Medical, Inc.(crm-sylmar).

MAUDE Entry Details

Report Number2017865-2019-17247
MDR Report Key9392093
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-08
Date Mfgr Received2019-11-08
Device Manufacturer Date2013-11-22
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 ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-0003-2018
Event Type3
Type of Report3

Device Details

Brand NameCD2257-40 FORTIFY ASSURA DR ICD_IDE_US
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNVZ
Date Received2019-11-29
Model NumberCD2257-40
Lot Number4358938
Device Expiration Date2015-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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