UNIFY ASSURA CRT-D RF HV CD3357-40Q

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for UNIFY ASSURA CRT-D RF HV CD3357-40Q manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

Event Text Entries

[185933781] No further information was available at this time. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185933782] It was reported that the device was found to be in backup operation.
Patient Sequence No: 1, Text Type: D, B5


[188140593] New information received notes that the device was restored and reprogrammed to its original settings. The patient was asymptomatic before, during, and after restoring the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2938836-2020-02367
MDR Report Key9908040
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-12
Device Manufacturer Date2016-08-12
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
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-SUNNYVALE)
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNIFY ASSURA CRT-D RF HV
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNIK
Date Received2020-03-31
Model NumberCD3357-40Q
Catalog NumberCD3357-40Q
Lot NumberA000026709
Device Expiration Date2018-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Address645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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