VICTORY XL DR 5816

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 2020-03-10 for VICTORY XL DR 5816 manufactured by Abbott.

Event Text Entries

[182712025] The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[182712026] During device replacement due to normal elective replacement indicator (eri), there was difficultly loosening the set screw to remove the ventricular lead. Additionally, the set screw to remove the atrial lead was unable to be loosened as the hex wrench was unable to fit in the set screw. Three different hex wrenches were used but were unsuccessful in fitting into the set screw. The atrial lead was cut and the device was explanted and replaced. The patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-03302
MDR Report Key9811001
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Device Manufacturer Date2007-08-09
Date Added to Maude2020-03-10
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 G1ABBOTT
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 NameVICTORY XL DR
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeDXY
Date Received2020-03-10
Model Number5816
Catalog Number5816
Lot Number2908846
Device Expiration Date2009-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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