MEDTRONIC LEAD MDT-LEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for MEDTRONIC LEAD MDT-LEAD manufactured by Medtronic, Inc..

Event Text Entries

[183924325] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183924326] It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to an infection. It was noted there was a plan to implant a leadless pacemaker as the patient is pacemaker dependent and implant a new crt-d system at a later date. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182208-2020-00514
MDR Report Key9843064
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-17
Date of Report2020-03-20
Date of Event2020-02-19
Date Mfgr Received2020-03-18
Date Added to Maude2020-03-17
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, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC LEAD
Generic NameDRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Product CodeDXY
Date Received2020-03-17
Model NumberMDT-LEAD
Catalog NumberMDT-LEAD
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-17

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