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 2020-03-30 for FORTIFY ASSURA DR ICD, US CD2357-40C manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185697692] 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


[185697693] It was reported that the implantable cardioverter defibrillator exhibited intermittent non-sustained ventricular over-sensing events which occurred on (b)(6) 2020 and (b)(6) 2020. It was noted that the over-sensing events were due to crosstalk or sensing of the atrial pace on the ventricular channel. Programming changes were discussed. No interventions were made at this time. There were no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04437
MDR Report Key9901609
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-23
Date Mfgr Received2020-03-11
Device Manufacturer Date2016-12-07
Date Added to Maude2020-03-30
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 Received2020-03-30
Model NumberCD2357-40C
Catalog NumberCD2357-40C
Lot NumberA000032887
Device Expiration Date2018-12-31
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
10 2020-03-30

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