IDENTITY ADX XL DR 5386

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 2020-03-27 for IDENTITY ADX XL DR 5386 manufactured by Abbott.

Event Text Entries

[185209332] 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


[185209333] During device replacement due to normal eri, a loss of pacing was observed following electrocautery use. The physician performed cardiac massage until pacemaker function returned. The event was resolved by explanting and replacing the device during the planned device replacement procedure due to normal eri. The patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04255
MDR Report Key9888400
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-19
Date Mfgr Received2020-03-20
Device Manufacturer Date2008-01-11
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameIDENTITY ADX XL DR
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeDXY
Date Received2020-03-27
Model Number5386
Catalog Number5386
Lot Number2904542
Device Expiration Date2009-07-31
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 2020-03-27

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