RIATA ACTIVE FIXATION 1580/65

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-30 for RIATA ACTIVE FIXATION 1580/65 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

MAUDE Entry Details

Report Number2938836-2019-16781
MDR Report Key9392639
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-18
Date Mfgr Received2019-11-20
Device Manufacturer Date2004-05-19
Date Added to Maude2019-11-30
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-SUNNYVALE)
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-0457-2012
Event Type3
Type of Report3

Device Details

Brand NameRIATA ACTIVE FIXATION
Generic NameDEFIBRILLATION LEAD
Product CodeNVY
Date Received2019-11-30
Model Number1580/65
Lot Number0002164554
Device Expiration Date2007-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Address645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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