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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMA1QQ
Device Problem Pacing Problem (1439)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 03/02/2024
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was reported that during preparation for a magnetic resonance imaging (mri) procedure, the mri access application was used to program the cardiac resynchronization therapy defibrillator (crt-d) to the mode used for mri procedure, and the patient rate dropped to forty beats per minute (bpm) which is below the crt-d programmed lower rate setting.  the patient was noted to be experiencing diaphragmatic stimulation while the left ventricular (lv) lead is in use.  an attempt was made to use the programmer to set the crt-d to the mode used for mri procedure and observed that when programmed to pacing in the atrium and ventricle mode, patient rate dropped to forty bpm when programmed to eighty bpm.   it was confirmed that the patient experienced stimulation with atrial paced events.Additionally, when the crt-d was programmed to pacing in the ventricle mode at eighty bpm, the patient rate was fine at eighty bpm.It was indicated that stimulation with atrial paced events and the rate dropping when the crt-d programmed to pacing in the atrium and ventricle mode at eighty bpm, suggest some type of lead issue.  the crt-d and lv lead remain in use.  no further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was further reported that the diaphragmatic stimulation was from atrial pacing.The right atrial (ra) lead was reprogrammed and remains in use.
 
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Brand Name
CLARIA MRI QUAD CRT-D SURESCAN
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ  1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ   1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key18980312
MDR Text Key338678462
Report Number9614453-2024-01205
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00763000059514
UDI-Public00763000059514
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/28/2023
Device Model NumberDTMA1QQ
Device Catalogue NumberDTMA1QQ
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2024
Date Device Manufactured03/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6935M55 LEAD, 5076-45 LEAD, 459888 LEAD
Patient Age56 YR
Patient SexMale
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