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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CLARIA MRI CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

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MEDTRONIC, INC. CLARIA MRI CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMA1D1
Patient Problems Cardiac Arrest (1762); Fall (1848); Respiratory Arrest (4461)
Event Date 05/03/2021
Event Type  Death  
Event Description
My deceased father, (b)(6), had one of the defibrillators that was included in the medtronic recall in the 7/18/2023 medwatch email.He had the claria mri, crtd dtma1d1, serial #(b)(6).The 7/18/2023 email from medwatch says that medtronic issued an urgent medical device correction notice to customers on 5/10/23.We never received anything from medtronic.I only know about the recall because i subscribe to medwatch notices.My father collapsed at approximately 8:15 am the morning of (b)(6) 2021.He was walking with his walker backwards into the bathroom and stopped in the doorway.He was having trouble standing and was slumping over his walker and said he needed to sit down.He could not reach the bench in the bathroom so he sat on the floor.As soon as he sat on the floor, his head dropped backwards to the floor and he stopped breathing.I was with him at the time; i am his daughter, (b)(6), and i called 911.We were not able to revive him and he died.A short while after my father died, i called his electrophysiologist, dr.(b)(6), and asked why his device did not shock him, and he said he did not know for sure but said it might have been a pulseless event.After reading the recall, i am wondering if he had a defective device and that's why it did not shock him.The recall notice said that no deaths were reported but we were never notified by medtronic about the defective device.I am also wondering why it took so long for medtronic to discover the problem.The recall says that devices distributed from 10/23/2017 to 6/9/2023 were being recalled.My father's device was implanted on (b)(6) 2019.I was in shock when my father died and did not have the presence of mind to ask the funeral parlor to remove the device from his body.I understand these types of devices are removed if the body is being cremated but that was not the case with my father.By the time i talked to the electrophysiologist, my father had already been embalmed and he was buried with the device.After i received the recall notice on 7/18/2023, i called the electrophysiologist and asked him if my father's device did not go off because of the problems with the device as detailed in the recall.He said it was a possibility but he also said that the last time he saw my father, in (b)(6) of 2021, he did not know about this problem with the device.He told me he would inform his medtronic representative and he would get back to me if he had any more information.I have not heard anything from the doctor or medtronic.How does medtronic know that no deaths were a consequence of defective devices since we never received a notice from medtronic about defective devices.Do they have to send notices to anyone who ever had one of the devices in the recall and/or to the family of deceased individuals?.
 
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Brand Name
CLARIA MRI CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key17690891
MDR Text Key322814367
Report NumberMW5145178
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberDTMA1D1
Device Lot NumberRPT207772H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2023
Patient Sequence Number1
Treatment
WALKER
Patient Outcome(s) Death;
Patient Age93 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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