PROTECTA CRT-D D364TRG

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 2020-03-30 for PROTECTA CRT-D D364TRG manufactured by Medtronic Europe Sarl.

Event Text Entries

[185980464] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185980465] It was reported that during the implant procedure, the cardiac resynchronization therapy defibrillator (crt-d) set screw was to deep into the header. It was not possible to loosen the screw. The device was noted used and another device was implanted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[187115737] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187115738] Additional information received noted the physician used four wrench kits. Some of the wrenches broke off or was distorted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614453-2020-01107
MDR Report Key9900911
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-31
Date of Event2020-03-23
Date Mfgr Received2020-03-23
Device Manufacturer Date2020-02-04
Date Added to Maude2020-03-30
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 EUROPE SARL
Manufacturer StreetROUTE DU MOLLIAU 31 CASE POSTALE
Manufacturer CityTOLOCHENAZ VAUD 1131
Manufacturer CountryCH
Manufacturer Postal Code1131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROTECTA CRT-D
Generic NameDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Product CodeNIK
Date Received2020-03-30
Model NumberD364TRG
Catalog NumberD364TRG
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EUROPE SARL
Manufacturer AddressROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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