EVERA? XT DR DDBB1D1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for EVERA? XT DR DDBB1D1 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185697965] Concomitant medical products: 7001 lead implanted: (b)(6) 2008. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185697966] It was reported by the patient's family that the patient passed away following the implantable cardioverter defibrillator (icd) replacement procedure. The family suspected the patient's death was related to the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06444
MDR Report Key9902961
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-07
Date Mfgr Received2020-03-05
Device Manufacturer Date2017-11-03
Date Added to Maude2020-03-31
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
Manufacturer CityJUNCOS PR 00777
Manufacturer CountryUS
Manufacturer Postal Code00777
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVERA? XT DR
Generic NameDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Product CodeLWS
Date Received2020-03-31
Model NumberDDBB1D1
Catalog NumberDDBB1D1
Device Expiration Date2019-04-28
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777


Patients

Patient NumberTreatmentOutcomeDate
16947651. Death 2020-03-31

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