FORTIFY ASSURA DR ICD, US CD2357-40C

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 2019-11-30 for FORTIFY ASSURA DR ICD, US CD2357-40C manufactured by St. Jude Medical, Inc.(crm-sylmar).

MAUDE Entry Details

Report Number2017865-2019-17251
MDR Report Key9392636
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-12
Date Mfgr Received2019-11-12
Device Manufacturer Date2014-02-10
Date Added to Maude2019-11-30
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORTIFY ASSURA DR ICD, US
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNVZ
Date Received2019-11-30
Model NumberCD2357-40C
Lot Number4463279
Device Expiration Date2016-02-29
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 2019-11-30

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