ISOFLEX OPTIM LEAD 1944/52

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 2019-11-29 for ISOFLEX OPTIM LEAD 1944/52 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

MAUDE Entry Details

Report Number2938836-2019-16757
MDR Report Key9392064
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-13
Date Mfgr Received2019-11-15
Device Manufacturer Date2019-04-18
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-SUNNYVALE)
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameISOFLEX OPTIM LEAD
Generic NamePERMANENT PACEMAKER ELECTRODE
Product CodeNVY
Date Received2019-11-29
Model Number1944/52
Lot NumberP000079817
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
101. Required No Informationntervention 2019-11-29

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