DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR 7170Q/58

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 2019-11-29 for DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR 7170Q/58 manufactured by St. Jude Medical, Inc.(crm-sylmar).

MAUDE Entry Details

Report Number2017865-2019-17242
MDR Report Key9392081
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-10
Date Mfgr Received2019-11-10
Device Manufacturer Date2011-11-30
Date Added to Maude2019-11-29
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 NameDURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
Generic NameDEFIBRILLATION LEAD
Product CodeNVY
Date Received2019-11-29
Model Number7170Q/58
Lot Number3570707
Device Expiration Date2012-11-30
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 2019-11-29

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