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,health report with the FDA on 2020-03-30 for UNIFY ASSURA CRT-D RF HV CD3357-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185699441] 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


[185699442] It was reported that the patient presented remotely via merlin. Net. Review of transmissions revealed that the implantable cardioverter defibrillator exhibited non-sustained right ventricular oversensing due to myopotential oversensing. The patient presented in clinic and the oversensing was reproducible with isometrics. Programming changes were made. The patient was stable throughout.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-03664
MDR Report Key9901530
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-09
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-11-07
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 NameUNIFY ASSURA CRT-D RF HV
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNIK
Date Received2020-03-30
Model NumberCD3357-40Q
Catalog NumberCD3357-40Q
Lot NumberA000089167
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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