CLARIA MRI CRT-D SURESCAN DTMA2D1

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 2020-03-31 for CLARIA MRI CRT-D SURESCAN DTMA2D1 manufactured by Medtronic Europe Sarl.

Event Text Entries

[186023725] Product event summary: the device was not returned for analysis. However, performance data collected from the device was received and analyzed. Analysis of the device memory showed the battery is approaching the indicator signifying the time for device replacement. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186023726] It was reported that ten days post implant procedure, the cardiac resynchronization therapy defibrillator (crt-d) had premature battery depletion caused by high threshold measurements of left ventricular (lv) lead. It was noted that the lv lead seem to increase or variate significantly in thresholds. It was also noted that anodal stimulation was observed at lv threshold pacing with high voltage. Due to the covid-19 regulations the patient will not be called in for reprogramming until it is safe. The device and lv lead remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614453-2020-01123
MDR Report Key9908079
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-10-07
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 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 NameCLARIA MRI CRT-D SURESCAN
Generic NameDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Product CodeNIK
Date Received2020-03-31
Model NumberDTMA2D1
Catalog NumberDTMA2D1
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrY
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 2020-03-31

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