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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMA1Q1
Medical Device Problem Code Reset Problem (3019)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 7122-65 lead, implanted: (b)(6) 2017; 459888 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) experienced an electrical reset due to a software glitch.The device was re-interrogated for diagnostic testing and remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CLARIA MRI QUAD CRT-D SURESCAN
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10309786
Report Number3004209178-2020-12643
Device Sequence Number19679268
Product Code NIK
UDI-Device Identifier00643169705760
UDI-Public00643169705760
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P010031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/22/2020
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
Operator of Device Lay User/Patient
Device Expiration Date04/28/2018
Device Model NumberDTMA1Q1
Device Catalogue NumberDTMA1Q1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2020
Initial Report FDA Received Date07/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
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