VERITY ADX SR 5156

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-27 for VERITY ADX SR 5156 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

Event Text Entries

[185248153] Further information was requested but not received. Analysis was normal. No anomalies were found.
Patient Sequence No: 1, Text Type: N, H10


[185248154] It was reported that the device was explanted due to infection. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2938836-2020-02253
MDR Report Key9889124
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-27
Date of Report2020-03-27
Date Mfgr Received2020-03-09
Device Manufacturer Date2006-03-21
Date Added to Maude2020-03-27
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 NameVERITY ADX SR
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeDXY
Date Received2020-03-27
Returned To Mfg2020-03-09
Model Number5156
Catalog Number5156
Lot Number0002312628
Device Expiration Date2007-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-03-27

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