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 2020-03-31 for FORTIFY ASSURA DR ICD, US CD2357-40C manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185940588] 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


[185940589] Related manufacturer reference number- 2017865-2020-03573. Related manufacturer reference number- 2017865-2020-03574. It was reported that the pacer dependent patient presented in clinic for follow-up. Upon interrogation, the right atrial lead exhibited noise. It was also noted that the right ventricular lead exhibited low sensing and oversensing resulting in inhibition. The leads were noted to be fractured. The patient was in stable condition. On (b)(6) 2020, the leads were capped and replaced. During the procedure, the implantable cardioverter defibrillator was also explanted and replaced due to an unspecified reason.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04152
MDR Report Key9908851
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2016-01-14
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 NameFORTIFY ASSURA DR ICD, US
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNVZ
Date Received2020-03-31
Model NumberCD2357-40C
Catalog NumberCD2357-40C
Lot NumberA000016554
Device Expiration Date2018-01-31
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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