QUADRA ASSURA CRT-D QUAD RF HV CD3365-40Q

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 2020-03-31 for QUADRA ASSURA CRT-D QUAD RF HV CD3365-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185941927] The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[185941928] The implantable cardioverter defibrillator was explanted and replaced. Further information was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04501
MDR Report Key9908544
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-09-19
Date Mfgr Received2020-03-20
Device Manufacturer Date2015-06-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameQUADRA ASSURA CRT-D QUAD RF HV
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNIK
Date Received2020-03-31
Returned To Mfg2020-03-20
Model NumberCD3365-40Q
Catalog NumberCD3365-40Q
Lot NumberA000008464
Device Expiration Date2017-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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
101. Required No Informationntervention 2020-03-31

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