UNIFY QUADRA CRT-D, US MODEL, DF4COMP CD3249-40Q

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 2020-03-31 for UNIFY QUADRA CRT-D, US MODEL, DF4COMP CD3249-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185941260] 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


[185941261] It was reported that the patient presented for a routine device exchange. Prior to generator change, device interrogation revealed that the implantable cardioverter defibrillator was far r wave oversensing that caused inappropriate mode switches. The device was reprogrammed to resolve the issue and was the explanted and replaced. Patient was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04502
MDR Report Key9908569
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Device Manufacturer Date2012-06-08
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-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 NameUNIFY QUADRA CRT-D, US MODEL, DF4COMP
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNIK
Date Received2020-03-31
Model NumberCD3249-40Q
Catalog NumberCD3249-40Q
Lot Number3724097
Device Expiration Date2013-12-31
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
101. Required No Informationntervention 2020-03-31

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